An observational study in Renal Cell Carcinoma (RCC) and Clear Cell Renal Cell Carcinoma (ccRCC), sponsored by The Affiliated Hospital of Qingdao University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by The Affiliated Hospital of Qingdao University · Observational
This study aims to evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-NY104 PET/CT in detecting primary, recurrent, and metastatic lesions of renal cell carcinoma (RCC), and to explore its potential for imaging and treatment response assessment in other CAIX-positive solid tumors, such as breast cancer and nasopharyngeal carcinoma, where high CAIX expression is associated with poor prognosis. The study will also investigate the effect of oral low-dose acetazolamide on the biodistribution of 18F-NY104, particularly in the stomach and kidneys.
Kidney disease affects more than 500 million people worldwide, including approximately 120 million individuals in China. Among various kidney diseases, renal cell carcinoma (RCC) represents one of the most serious malignant conditions affecting the kidney and is one of the most common malignancies of the urinary system. The incidence of RCC in China has increased in recent years. Early-stage RCC is often asymptomatic and may be detected incidentally during routine health examinations. However, RCC is an aggressive malignancy, and a substantial proportion of patients present with metastatic disease at initial diagnosis or develop recurrence and metastasis after surgery. Therefore, accurate detection of primary, recurrent, and metastatic lesions is important for diagnosis, staging, restaging, treatment planning, and prognosis assessment.
Carbonic anhydrase IX (CAIX) is a transmembrane glycoprotein of the carbonic anhydrase family and is closely associated with the von Hippel-Lindau (VHL)/hypoxia-inducible factor (HIF) signaling pathway. By regulating intracellular and extracellular pH under hypoxic conditions, CAIX contributes to tumor cell survival, proliferation, invasion, and metastasis. CAIX has limited expression in most normal tissues but is highly expressed in RCC, particularly clear cell RCC, making it an attractive molecular target for tumor imaging and therapy. Moreover, CAIX overexpression is observed in a variety of other solid tumors, including breast cancer and nasopharyngeal carcinoma, and has been associated with tumor hypoxia, aggressive tumor characteristics, and poor prognosis. Thus, non-invasive assessment of CAIX expression may provide clinically relevant information for tumor detection, characterization, prognosis assessment, and treatment response evaluation in RCC and other CAIX-positive solid tumors.
18F-NY104 is a novel CAIX-targeted PET imaging agent with favorable radiochemical and imaging characteristics. Preclinical studies have demonstrated its specific binding to CAIX expressed on tumor cells, as well as favorable pharmacokinetics and imaging performance, supporting its potential for non-invasive, whole-body assessment of CAIX-positive tumors.
This study will evaluate the diagnostic performance of 18F-NY104 PET/CT for detecting primary, recurrent, and metastatic RCC lesions and explore its potential application in other CAIX-positive solid tumors, including breast cancer and nasopharyngeal carcinoma. Its potential value for non-invasive assessment of CAIX expression and treatment response will also be investigated. In addition, the study will evaluate the effect of oral low-dose acetazolamide, a CAIX inhibitor, on the biodistribution of 18F-NY104, particularly physiological uptake in the stomach and kidneys, and its potential impact on lesion visualization and image interpretation.
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
This study's planned enrollment of 120 is below the median of 151 across 337 observational studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →The Affiliated Hospital of Qingdao University is the lead sponsor of 149 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The cohort primarily included patients who were clinically diagnosed with or suspected to have renal cell carcinoma (RCC), those with suspected recurrence or metastasis after treatment of RCC, and patients with CAIX-positive solid tumors, including but not limited to breast cancer and nasopharyngeal carcinoma.
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.
Laboratory parameters must meet:
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Radiation: 18F-NY104 PET/CT
The radionuclide ¹⁸F will serve as the tracer in this study. NY104 will be labeled with \[¹⁸F\]AlF to form the ¹⁸F-NY104 injection for use in this research.All participants will undergo ¹⁸F-NY104 PET scan.
SUV
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
Time frame: 2 years
Plan to share: No
Started Apr 2025 (actual). Primary completion is estimated for Dec 2027, 32 months after the start.
Of 97 non-industry observational studies under Carcinoma, Renal Cell, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 241. This study's planned 32 months is below that.
Counting every sponsor, half of 139 studies reached it within 50 months; a quarter within 33 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
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The Affiliated Hospital of Qingdao University →