Trop2-targeted immunoPET Imaging of Solid Tumors

Last updated: May 27, 2026
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Lung Cancer

Carcinoma

Bladder Cancer

Treatment

[18F]F-RESCA-RT4

[68Ga]Ga-NOTA-T4

[18F]F-RESCA-T4

Clinical Study ID

NCT06851663
LY2024-307-A
  • Ages 18-75
  • All Genders

Study Summary

This study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18-75 year-old and of either sex

  • Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer,bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer,cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroidcancer, head and neck cancer) or suspected solid tumors (including uroepithelialcancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, livercancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer,thyroid cancer, head and neck cancer) by diagnostic imaging;

  • Capable of giving signed informed consent, including compliance with therequirements and restrictions in the informed consent form (ICF) and this protocol.

Exclusion

Exclusion Criteria:

  • Pregnancy；

  • Severe hepatic and renal insufficiency;

  • Allergic to single-domain antibody radiopharmaceuticals.

Study Design

Total Participants: 400
Treatment Group(s): 4
Primary Treatment: [18F]F-RESCA-RT4
Phase: 2/3
Study Start date:
December 23, 2024
Estimated Completion Date:
December 31, 2027

Study Description

Histologically confirmed solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer), or patients with suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) indicated by conventional diagnostic imaging will be included. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.For patients with prostate cancer or suspected prostate cancer, head-to-head comparisons with PSMA PET are still needed.

Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors and normal organs/tissues will be scored visually and quantitatively.

Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.

Connect with a study center

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, 200127
    China

    Active - Recruiting

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