Trop2-targeted immunoPET Imaging of Solid Tumors

Not Applicable

Recruiting

• Conditions: Solid Tumor; Solid Carcinoma; Bladder Cancer; Cholangiocarcinoma; Ovarian Cancer; Cervical Cancer; Endometrial Cancer; Uroepithelial Carcinoma; Nasopharyngeal Cancer; Liver Cancer
• Interventions: Drug: [68Ga]Ga-NOTA-T4; Drug: [68Ga]Ga-NOTA-RT4; Drug: [18F]F-RESCA-T4; Drug: [18F]F-RESCA-RT4

• Registration Number: NCT06851663
• Lead Sponsor: RenJi Hospital

Brief 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.

Study Timeline

• Study Start: 2024-12-23
• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trop2-targeted immunoPET imaging	[68Ga]Ga-NOTA-T4	Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.
Trop2-targeted immunoPET imaging	[68Ga]Ga-NOTA-RT4	Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.
Trop2-targeted immunoPET imaging	[18F]F-RESCA-T4	Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.
Trop2-targeted immunoPET imaging	[18F]F-RESCA-RT4	Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.

Primary Outcome Measures

Name	Time	Method
Radiation dosimetry of tissues/organs	1 day from injection of the tracers	Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs. The following tissues were included: adrenals, brain, breasts, gallbladder, small intestine, upper and lower large intestine, stomach, heart contents, heart muscle, kidney, liver, lung, muscle, ovaries, pancreas, red marrow, trabecular and cortical bone, spleen, testes, thymus, thyroid, urinary bladder, and uterus. Dynamic imaging within one hour will be performed for this purpose.
Radiation dosimetry of tumors	1 day from injection of the tracers	Measurement of absorbed radiation doses (Gy/MBq) to tumors. Dynamic imaging within one hour will be performed for this purpose.
Radiation dosimetry of whole-body	1 day from injection of the tracers	Whole-body activity was measured using a large volume of interest (VOI) covering the entire subject.
Diagnostic sensitivity	30 days	Sensitivity = (True Positives) / (True Positives + False Negatives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Diagnostic specificity	30 days	Specificity = (True Negatives) / (True Negatives + False Positives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Accuracy	30 days	Accuracy = (True Positives + True Negatives) / (Total Tests). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Positive Predictive Value (PPV)	30 days	PPV = (True Positives) / (True Positives + False Positives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Negative Predictive Value (NPV)	30 days	NPV = (True Negatives) / (True Negatives + False Negatives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.	1 day from injection of the tracers	Measurement of the overall biodistribution of the above tracers in normal tissues and organs (bladder (after voiding), background (pelvic fat), blood, brain, salivary and lacrimal glands, lung, liver, spleen, pancreas, small intestine, and kidneys). To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
SUV of tumors	1 day from injection of the tracers	The SUV of the above tracers in the primary and/or metastatic lesions of the included subjects. To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.

Secondary Outcome Measures

Name	Time	Method
Trop2 immunoPET/CT in altering initial staging for patients with solid tumors	3-6 months	Assess the role of Trop2 immunoPET/CT in initial staging in terms of the number of metastases.
Trop2 immunoPET/CT for restaging for patients with solid tumors	3-6 months	Assess the role of Trop2 immunoPET/CT in restaging in terms of the number of metastases, Trop2-TV, and Trop2-TLU.
Trop2 immunoPET/CT for postoperative surveillance for patients with solid tumors	3-6 months	Assess the role of Trop2 immunoPET/CT in surveillance in terms of the number of metastases, Trop2-derived tumor volume (Trop2-TV), and total lesion Trop2 uptake (Trop2-TLU).
Trop2 immunoPET/CT in evaluating treatment responses	1-2 years	We will also investigate the role of Trop2 immunoPET/CT in predicting and evaluating the treatment efficacy in patients with 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). The treatment regimens vary for different tumor types but involve chemotherapy, molecularly targeted therapies, immunotherapies (e.g. PD-1/PD-L1 inhibitors), and cell therapies.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China