NCT06851663

Trop2-targeted immunoPET Imaging of Solid Tumors

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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. 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.

Conditions

• Solid Tumor
• Solid Carcinoma
• Uroepithelial Carcinoma
• Bladder Cancer
• Prostate Cancer
• Lung Cancer
• Nasopharyngeal Cancer
• Liver Cancer
• Cholangiocarcinoma
• Ovarian Cancer
• Cervical Cancer
• Endometrial Cancer
• Thyroid Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-23
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-02-28
• Last updated: 2025-12-08

Locations

1 site across 1 country: China