Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors

Not Applicable

Recruiting

• Conditions: Neoplasms; Positron-Emission Tomography
• Interventions: Radiation: [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4

• Registration Number: NCT06203574
• Lead Sponsor: Huashan Hospital

Brief Summary

This study will investigate the safety and preliminary diagnostic efficacy of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 in pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. Then, this study will provide a new method for the noninvasive target-specific diagnosis of pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. PET imaging of TROP-2 will be integrated to TROP-2-targeted therapies in some of the included patients. Therefore, PET imaging with \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 will help select patients for targeted therapy and monitor treatment responses after the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Be between 18 and 65 years of age and of either sex.
2. Patients with colorectal cancer confirmed by puncture or surgical pathology.
3. Written informed consent signed by the subject or legal guardian or caregiver.
4. Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria

1. Severe hepatic or renal insufficiency;
2. Targeted therapy before radiotherapy or PET/CT scan；
3. Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range；
4. History of serious surgery in the last month. Those who have participated in other clinical trials during the same period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with solid tumors	[68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4	Subjects were recruited from Huashan Hospital of Fudan University.

Primary Outcome Measures

Name	Time	Method
evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT	1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4	The third goal is to evaluate the value of TROP-2 expression determined by \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT in differential diagnosis, patient selection, and response monitoring in patients with solid tumors.
evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression	1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4	The secondary goal is to evaluate the sensitivity and specificity of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression.
evaluate the safety and feasibility of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors	1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4	The primary goal of the study is to evaluate the distribution profiles (in terms of SUVmax) of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors.

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, China