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

NCT ID: NCT06911697

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-26
• Study Completion Date: 2025-06-28

Brief Summary

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.

Detailed 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.

Conditions

PET/CT Imaging; NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental: 18F-TSPF

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

Group Type: EXPERIMENTAL

18F-TSPF PET/CT

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

18F-TSPF PET/CT

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Xilin Sun

OTHER

Sponsor Role: lead

Responsible Party

Xilin Sun

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Nuclear Medicine, Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xilin Sun, MD

Role: CONTACT

sunxilin@aliyun.com

+86-15904601908

Facility Contacts

Xilin Sun, MD

Role: primary

sunxilin@aliyun.com

+86-15904601908

Other Identifiers

2023-LLSC-23

Identifier Type: OTHER

Identifier Source: secondary_id

2023-LLSC-23

Identifier Type: -

Identifier Source: org_study_id