Trop2-targeted immunoPET Imaging of Solid Tumors

Overview

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.

Detailed 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.

Interventions

• Drug [68Ga]Ga-NOTA-T4
  Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-T4 injection.
• Drug [68Ga]Ga-NOTA-RT4
  Enrolled patients will receive 0.05-0.1 mCi/kg of \[68Ga\]Ga-NOTA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-RT4 injection.
• Drug [18F]F-RESCA-T4
  Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-T4 injection.
• Drug [18F]F-RESCA-RT4
  Enrolled patients will receive 0.05-0.1 mCi/kg of \[18F\]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RT4 injection.

Primary outcome measures

• Biodistribution-Standardized uptake value (SUV) of normal tissues and organs. [Time frame: 1 day from injection of the tracers]
• SUV of tumors [Time frame: 1 day from injection of the tracers]
• Radiation dosimetry of tissues/organs [Time frame: 1 day from injection of the tracers]
• Radiation dosimetry of tumors [Time frame: 1 day from injection of the tracers]
• Radiation dosimetry of whole-body [Time frame: 1 day from injection of the tracers]
• Diagnostic sensitivity [Time frame: 30 days]
• Diagnostic specificity [Time frame: 30 days]
• Accuracy [Time frame: 30 days]
• Positive Predictive Value (PPV) [Time frame: 30 days]
• Negative Predictive Value (NPV) [Time frame: 30 days]

Secondary outcome measures (5)

• Trop2 immunoPET/CT in altering initial staging for patients with solid tumors [Time frame: 3-6 months]
• Trop2 immunoPET/CT for postoperative surveillance for patients with solid tumors [Time frame: 3-6 months]
• Trop2 immunoPET/CT for restaging for patients with solid tumors [Time frame: 3-6 months]
• Trop2 immunoPET/CT in evaluating treatment responses [Time frame: 1-2 years]
• Whole-body tumor burden（Trop2/PSMA-TV and TL-Trop2/PSMA） [Time frame: 30 days]

Eligibility criteria

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, thyroid cancer, head and neck cancer) or 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) by diagnostic imaging;
• Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.

Exclusion criteria

• Pregnancy；
• Severe hepatic and renal insufficiency;
• Allergic to single-domain antibody radiopharmaceuticals.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

China · 1 center

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

Publications

• Long X, An S, Nian X, Xu D, Wei W, Lan X, Dong L, Jiang D. Trop2 immuno-PET/CT imaging of prostate cancer: a proof-of-concept translational study. BMC Med. 2025 Dec 31;24(1):66. doi: 10.1186/s12916-025-04589-8. PMID 41469668

Identifiers

NCT: NCT06851663 · LY2024-307-A

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗