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Not yet recruitingNCT07707999Updated Jul 16, 2026

Clinical Application of FAP-Targeted Radionuclide Imaging in the Diagnosis and Staging of Malignant Solid Tumors

An Early Phase 1 interventional study of Novel FAP-targeted probe in Malignant Neoplasm, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Early Phase 1, Interventional, and Diagnostic

Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

This study is a single-center, open-label first-in-human clinical study. Patients with clinically suspected or confirmed malignant solid tumors will undergo [68Ga]Ga-FAP PET imaging or [177Lu]Lu-FAP SPECT imaging as well as [18F]FDG PET imaging to determine the presence or absence of lesions, and to assess lesion location, characteristics, and metastasis. Histopathological diagnosis or follow-up results will serve as the reference standard. The diagnostic efficacy of [68Ga]Ga-FAP PET imaging or [177Lu]Lu-FAP SPECT imaging for malignant tumors will be evaluated. Additionally, the study will analyze the biodistribution and dosimetry of [177Lu]Lu-FAP following a single administration, explore the correlation between tumor uptake values on imaging and immunohistochemical FAP expression levels, and evaluate the safety and tolerability of a single low-dose intravenous injection of [68Ga]Ga-FAP or [177Lu]Lu-FAP for diagnostic imaging.

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Conditions studied

  • Malignant Neoplasm

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 160 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntary participation and the patient or their legal representative is able to sign an informed consent form.
  2. Adult patients (aged 18 or above), regardless of gender.
  3. Patients with an ECOG performance status of 0 to 1 and able to tolerate PET and SPECT/CT examinations.
  4. Patients with histopathologically or clinically confirmed malignant solid tumors who have measurable lesions according to RECIST 1.1 criteria.
  5. Patients with expected survival>6 months.
  6. Female patients of childbearing potential must have a negative pregnancy test, and all patients (including male patients) agree to use effective contraceptive measures during the study period and for at least three months after study drug administration.

Exclusion criteria

Exclusion Criteria:

  1. Patients who are pregnant or breastfeeding, or plan to become pregnant during the study period or within three months after study drug administration (excluding those who have been postmenopausal for at least one year, or those who are surgically sterilized, such as bilateral tubal ligation without recanalization, bilateral oophorectomy, or hysterectomy); or patients who plan to donate sperm or eggs during the study period or within three months after study drug administration.
  2. Patients with known or suspected allergy to the investigational drug or any of its components, or patients with severe allergic constitution.
  3. Patients who have undergone procedures within 6 months prior to study entry that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion.
  4. Patients with positive syphilis or HIV test results at screening.
  5. Patients with abnormal liver or kidney function: serum total bilirubin (TBIL) > 31.5 umol/L; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 120 U/L, or > 200 U/L if the elevation is considered to be related to liver metastases from solid tumors; serum creatinine (Scr) > 150 umol/L, or creatinine clearance \< 60 mL/min (according to the Cockcroft-Gault formula).
  6. Patients with abnormal bone marrow parameters: absolute neutrophil count \< 1.5 x 10\^9/L, hemoglobin \< 10 g/dL, serum albumin \< 2.8 g/dL (normal range 3.5-5.5 g/dL), platelets \< 100 x 10\^9/L (normal range 100-300 x 10\^9/L), international normalized ratio (INR) > 1.5 (normal range 0.8-1.3) in patients not taking warfarin, or prothrombin time (PT) > 2 x ULN (normal range 11-15 seconds).
  7. Patients with active infection (e.g., acute bacterial infection, tuberculosis, active hepatitis B/C, active syphilis, etc.). Active hepatitis B is defined as: positive HBsAg or HBcAb, or results outside the normal reference range, accompanied by hepatitis B virus DNA titer > 2500 copies/mL or > 500 IU/mL. Active hepatitis C is defined as: positive hepatitis C antibody, or results outside the normal reference range, and positive HCV-RNA.
  8. Patients with dysuria or urinary incontinence due to any cause.
  9. Patients with claustrophobia or other conditions that preclude cooperation with PET/MR and SPECT/CT examinations.
  10. Patients with psychiatric disorders such as depressive symptoms, schizophrenia, delusions, hallucinations, or suicidal ideation.
  11. Patients with severe cardiovascular disease, including but not limited to New York Heart Association (NYHA) class II to IV congestive heart failure, or left ventricular ejection fraction (LVEF) \< 50% or below the lower limit of normal.
  12. Patients with other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this study.
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Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    PET/SPECT imaging of novel FAP-targeted probe in malignant neoplasm

    This project aims to perform integrated SPECT/CT or PET/MR imaging in patients with histologically confirmed malignant neoplasms with high fibroblast activation protein (FAP) expression. This study utilizes a FAP-specific PET/SPECT imaging probe to evaluate the feasibility, accuracy, and clinical value in malignant neoplasm.

    Drug: Novel FAP-targeted probe

Interventions

  • DrugNovel FAP-targeted probe

    For Cancer patients, subjects should have targeting FAP scans

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What researchers measure

Primary outcomes

  1. Visual and standardized uptake values assessment of lesions and biodistribution

    At least two experienced nuclear medicine physicians will analyze the images, using histopathological diagnosis or follow-up findings as the reference standard.The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case.

    Time frame: 1 month

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Study locations

1 site
  • Wuhan union hosptital
    Wuhan, Hubei, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07707999
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Responsible party
Sponsor
First posted
Jul 16, 2026
Start date
Jul 30, 2026 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jul 16, 2026

Study contacts

Xiaoli Lan, PhD
Contact
lxl730724@hotmail.com
0086-027-83692633

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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