Study on c-Met Targeted PET/CT Imaging in NSCLC

Xilin Sun

Status: Enrolling

Conditions: PET/CT Imaging; NSCLC

Treatments: Diagnostic Test: 18F-TSPF PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT06911697

2023-LLSC-23 (Other Identifier)

Details and patient eligibility

About

The investigators developed a 18F labeled small molecule, 18F-TSPF, based on c-Met TKI, as a targeted molecular imaging agent for noninvasive and repeatable detecting c-Met activation status.

Full description

In the study, NSCLC patients with different c-Met activation status (c-Met overexpression, MET exon 14 skipping mutation, MET amplification, MET wild type) confirmed by pathology or gene detection will receive 18F-TSPF PET/CT and 18F-FDG PET/CT respectively. The goal of the study is to evaluate specificity and accuracy of 18F-TSPF as a novel PET radiotracer to detect c-Met activation status and potentially identify c-Met-TKIs benefited NSCLC patients.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age range 18-75 years, open to both male and female participants;
2. Normal hepatic/renal function and cardiac function;
3. Expected survival of at least 12 weeks;
4. Good adherence to follow-up;
5. Presence of at least one measurable target lesion according to RECIST 1.1 criteria;
6. Women of childbearing age (15-49 years) must undergo a pregnancy test within seven days prior to the commencement of the study and test negative; sexually active male and female participants must agree to utilize effective contraception to prevent pregnancy during the study and for three months following the final examination;
7. Patients for whom a clinical physician recommends PET/CT scans for the diagnosis and staging of tumors;
8. Participants must fully understand and voluntarily agree to participate in the study, and must sign an informed consent form.

Exclusion criteria

1. Severe abnormalities in liver and renal function and blood counts;
2. Patients planning to conceive;
3. Pregnant or lactating women;
4. Individuals unable to lie flat for thirty minutes;
5. Individuals who refuse to participate in this clinical study;
6. Individuals suffering from claustrophobia or other psychiatric disorders;
7. Other situations deemed unsuitable for trial participation by the researchers.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Experimental: 18F-TSPF

Experimental group

Description:

Each subject receives interval imaging of 18F-TSPF PET/CT and 18F-FDG PET/CT.

Treatment:

Diagnostic Test: 18F-TSPF PET/CT