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

N/ARecruitingNCT06203574

Huashan Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Positron-Emission Tomography Neoplasms

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

evaluate the safety and feasibility of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors

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.

Time frame: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4

evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression

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.

Time frame: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4

evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT

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.

Time frame: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts