An interventional study of 68Ga-SorB PET/CT in Melanoma (Skin Cancer), Hepatocellular Carcinoma and Lung Cancer, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Diagnostic
Among 202 studies in Melanoma with a site in China — 82 open to participants now, 95 under way, 5 of them phase 3. Melanoma · China.
Among the 202 studies in Melanoma with a site in China, this one is the 95th largest by planned enrollment of the 188 interventional ones that give a count, is one of 19 that started in 2026, is one of 8 with no phase, reaches primary completion later than 61 of the 94 other live ones, and was the 198th registered.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
Browse Melanoma studies →82 of the 202 studies in Melanoma with a site in China are open now. Recruiting first, the newest first:
Sichuan Baili Pharmaceutical Co., Ltd. · Sites in China
Sun Yat-sen University · Sites in China
Bristol-Myers Squibb · Sites in China, United States, Belgium and 10 more countries
Shanghai Henlius Biotech · Sites in China
West China Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 467 Melanoma studies recruiting now, 380 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
202 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 91 · Phase 2 109 · Phase 3 13 · Phase 4 2
First in 2008; this study’s year is marked. 19 started in 2026.
This study's planned enrollment of 50 is above the median of 40 across 2,649 interventional studies indexed under Melanoma.
Median enrollment 52 across the 188 interventional studies, 75 across the 14 observational. Of the 43 that completed or were terminated, 12 (28%) have results posted.
This tab as a report to print or save as PDF → With an account.
100 of 202 have an industry lead sponsor. The 10 most frequent:
Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
Peking University Third Hospital has 1 study filed under Melanoma — fewer than ten, so there is no comparison to draw.
24 of the studies in Melanoma with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06008106Phase 3Shanghai Kechow Pharma, Inc.Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma | 2027-09-22 |
| NCT07280832Shanghai JMT-Bio Inc.Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma and Urinary Tract Tumors | 2026-11-30 |
| NCT06359860Beijing Scitech-Mq Pharmaceuticals LimitedA Study of ST-1898 for Unresectable or Metastatic Melanoma | 2026-12 |
| NCT07586891Xijing HospitalExploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Branched-Chain Amino Acid Diet in Combination With Anti-PD-1 Monoclonal Antibody for Stage III Melanoma | 2026-12 |
| NCT07586904Xijing HospitalEfficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III/IV Melanoma. | 2026-12 |
Among the 202 studies in Melanoma with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This prospective, single-center, open-label exploratory diagnostic study aims to evaluate the safety, feasibility, and diagnostic performance of the novel Sortilin-targeted PET tracer 68Ga-SorB in patients with solid tumors. Eligible participants with confirmed or suspected melanoma, hepatocellular carcinoma, lung cancer, pancreatic cancer, breast cancer, ovarian cancer, or cholangiocarcinoma will undergo 68Ga-SorB PET/CT imaging. The imaging findings will be compared with standard-of-care 18F-FDG PET/CT, using pathology results and/or clinical follow-up as the reference standard.
The primary objectives are to evaluate the safety and tolerability of 68Ga-SorB, assess imaging feasibility, and characterize tumor uptake using quantitative PET parameters, including SUVmax and tumor-to-background ratio (TBR). Secondary exploratory objectives include comparing lesion detection between 68Ga-SorB PET/CT and 18F-FDG PET/CT, assessing diagnostic sensitivity and specificity, evaluating imaging characteristics across different tumor types, and exploring the correlation between Sortilin expression and tracer uptake. This study will provide preliminary clinical evidence supporting the development of Sortilin-targeted molecular imaging and future theranostic applications.
Background Sortilin is a type I transmembrane receptor belonging to the VPS10 receptor family. It is highly expressed in a variety of malignancies, including melanoma, hepatocellular carcinoma, lung cancer, pancreatic cancer, breast cancer, ovarian cancer, and cholangiocarcinoma, while showing relatively low expression in most normal tissues. Due to its tumor-specific expression pattern and efficient receptor-mediated internalization, Sortilin has emerged as a promising molecular target for cancer imaging and targeted theranostic applications.
Although \^18F-FDG PET/CT is widely used for oncologic imaging, its diagnostic performance may be limited by nonspecific uptake in inflammatory lesions, resulting in false-positive findings. Therefore, a more tumor-specific PET tracer may improve lesion detection and diagnostic accuracy.
Study Design This is a prospective, single-center, open-label, exploratory diagnostic imaging study designed to evaluate the clinical performance of the novel Sortilin-targeted PET radiotracer \^68Ga-SorB. Approximately 40-50 adult patients with confirmed or suspected melanoma, hepatocellular carcinoma, lung cancer, pancreatic cancer, breast cancer, ovarian cancer, or cholangiocarcinoma will be enrolled. All participants will undergo \^68Ga-SorB PET/CT imaging according to the study protocol. Standard-of-care \^18F-FDG PET/CT performed within the predefined time window will be used as the comparator whenever available.
Histopathological findings and/or clinical and imaging follow-up will serve as the reference standard for evaluating diagnostic performance.
Study Objectives The primary objectives are to evaluate the safety and tolerability of \^68Ga-SorB, assess imaging feasibility, and characterize tracer biodistribution and tumor uptake using quantitative PET parameters, including SUVmax and tumor-to-background ratio (TBR).
Secondary exploratory objectives include comparison of lesion detection between \^68Ga-SorB PET/CT and \^18F-FDG PET/CT, estimation of diagnostic sensitivity, specificity, and accuracy, evaluation of tracer uptake across different tumor types, assessment of the association between Sortilin expression and imaging parameters, and exploration of the potential clinical value of \^68Ga-SorB PET/CT in tumor diagnosis and staging.
Study Significance This exploratory clinical study is expected to generate preliminary evidence regarding the safety, feasibility, and diagnostic performance of \^68Ga-SorB PET/CT in patients with solid tumors. The results may support further multicenter validation studies and facilitate the clinical development of Sortilin-targeted molecular imaging and future theranostic strategies.
The criteria were revised on the registry on Oct 15, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with suspected or confirmed malignant tumors will receive a single intravenous administration of 68Ga-SorB followed by PET/CT imaging. Imaging findings will be compared with clinically indicated 18F-FDG PET/CT performed within the predefined time window. No therapeutic intervention will be administered as part of this study.
Diagnostic Test: 68Ga-SorB PET/CT
Participants will receive a single intravenous administration of 68Ga-SorB (approximately 3.7 MBq/kg), followed by whole-body PET/CT imaging approximately 60 minutes after injection. The imaging findings will be compared with clinically indicated 18F-FDG PET/CT and reference standard findings to evaluate the safety, feasibility, biodistribution, tumor uptake, and exploratory diagnostic performance of 68Ga-SorB PET/CT.
Incidence of adverse events related to 68Ga-SorB PET/CT
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) related to administration of 68Ga-SorB, graded according to CTCAE.
Time frame: From tracer administration until completion of the imaging visit (approximately 24 hours).
Successful completion of 68Ga-SorB PET/CT imaging
Proportion of participants completing 68Ga-SorB PET/CT with evaluable image quality.
Time frame: At completion of PET/CT imaging (approximately 60 minutes after tracer injection)
Tumor uptake of 68Ga-SorB measured by SUVmax
Maximum standardized uptake value (SUVmax) of target lesions measured on 68Ga-SorB PET/CT.
Time frame: At PET/CT imaging (approximately 60 minutes after tracer injection)
Lesion detection rate on 68Ga-SorB PET/CT
Detection rate of reference standard-confirmed primary and metastatic tumor lesions visually identified on 68Ga-SorB PET/CT. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians. The detection rate will be calculated as the percentage of reference standard-confirmed lesions detected on 68Ga-SorB PET/CT. The reference standard will include pathology, clinical diagnosis, and/or imaging follow-up, as applicable.
Time frame: At completion of 68Ga-SorB PET/CT imaging, with reference-standard adjudication up to approximately 3 months after imaging.
Cohen's kappa coefficient for lesion detection agreement between 68Ga-SorB PET/CT and 18F-FDG PET/CT
Agreement in lesion detection between 68Ga-SorB PET/CT and clinically indicated 18F-FDG PET/CT. For each evaluable lesion, detection status will be recorded as detected or not detected on each PET/CT modality based on lesion-based visual image interpretation by nuclear medicine physicians. Agreement between the two PET/CT modalities will be assessed using Cohen's kappa coefficient with 95% confidence interval. Unit of Measure: Cohen's kappa coefficient, unitless.
Time frame: Within 2 weeks after completion of both PET/CT examinations.
Diagnostic sensitivity of 68Ga-SorB PET/CT for lesion detection
Diagnostic sensitivity of 68Ga-SorB PET/CT for lesion detection will be calculated using pathology, clinical diagnosis, and/or imaging follow-up as the reference standard. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians. Unit of Measure: Percentage.
Time frame: Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
Tumor SUVmax on 68Ga-SorB PET/CT by tumor type
Maximum standardized uptake value of tumor lesions on 68Ga-SorB PET/CT across different tumor types, including malignant melanoma, hepatocellular carcinoma, lung cancer, breast cancer, pancreatic cancer, ovarian cancer, and cholangiocarcinoma, as applicable. SUVmax will be measured on fused PET/CT images using ROI/VOI delineation. Unit of Measure: Unitless standardized uptake value.
Time frame: At completion of 68Ga-SorB PET/CT imaging, approximately 60 minutes after tracer administration.
Correlation between Sortilin expression H-score and 68Ga-SorB PET/CT uptake parameters
Correlation between Sortilin expression in pathological tumor specimens and quantitative 68Ga-SorB PET/CT uptake parameters, including SUVmax and tumor-to-background ratio. For participants with available tissue samples, Sortilin expression will be measured by immunohistochemistry and reported as an H-score. SUVmax and tumor-to-background ratio will be measured on fused PET/CT images using ROI/VOI delineation. Correlation will be assessed using Pearson correlation analysis or Spearman rank correlation analysis, as appropriate. Unit of Measure: Correlation coefficient, unitless. Underlying Variable Units: Sortilin H-score, score range 0-300; SUVmax, unitless standardized uptake value; tumor-to-background ratio, unitless ratio.
Time frame: Within approximately 3 months after PET/CT imaging, following completion of pathological assessment.
Percentage of participants with a change in clinical diagnosis or tumor staging after 68Ga-SorB PET/CT
Percentage of participants whose clinical diagnosis or tumor staging changes after review of 68Ga-SorB PET/CT findings compared with the pre-PET/CT assessment based on standard imaging and clinical information. Changes in clinical diagnosis or tumor stage will be determined by investigator review of available clinical, imaging, pathological, and follow-up information. Unit of Measure: Percentage of participants.
Time frame: Within approximately 3 months after 68Ga-SorB PET/CT imaging.
Diagnostic specificity of 68Ga-SorB PET/CT for lesion detection
Diagnostic specificity of 68Ga-SorB PET/CT for lesion detection will be calculated using pathology, clinical diagnosis, and/or imaging follow-up as the reference standard. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians. Unit of Measure: Percentage.
Time frame: Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
Diagnostic accuracy of 68Ga-SorB PET/CT for lesion detection
Diagnostic accuracy of 68Ga-SorB PET/CT for lesion detection will be calculated using pathology, clinical diagnosis, and/or imaging follow-up as the reference standard. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians. Unit of Measure: Percentage.
Time frame: Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
Positive predictive value of 68Ga-SorB PET/CT for lesion detection
Positive predictive value of 68Ga-SorB PET/CT for lesion detection will be calculated using pathology, clinical diagnosis, and/or imaging follow-up as the reference standard. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians. Unit of Measure: Percentage.
Time frame: Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
Negative predictive value of 68Ga-SorB PET/CT for lesion detection
Negative predictive value of 68Ga-SorB PET/CT for lesion detection will be calculated using pathology, clinical diagnosis, and/or imaging follow-up as the reference standard. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians. Unit of Measure: Percentage.
Time frame: Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
Plan to share: No — Individual participant data will not be made publicly available because of participant privacy considerations and institutional data-sharing policies.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2027, 16 months after the start.
Of 219 non-industry interventional studies with no phase under Melanoma, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 62. This study's planned 16 months is below that.
Counting every sponsor, half of 227 studies reached it within 38 months; a quarter within 20 and three quarters within 62.
Start moved once since we started tracking on Sep 25, 2026: Jul 2026 → Aug 2026, on Oct 15, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Peking University Third Hospital →