RecruitingPhase 2Phase 3NCT06851663

Trop2-targeted immunoPET Imaging of Solid Tumors

Sponsor

RenJi Hospital

Enrollment

400 participants

Start Date

Dec 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

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 Criteria3

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

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.