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

In Vivo Detection of c-Met Activation Status by Specific PET/CT Imaging Based on 18F Labeled Small Molecule TKI

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC; PET/CT Imaging
• Intervention / Treatment: Diagnostic test: 18F-TSPF PET/CT

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xilin Sun, MD; Phone Number: +86-15904601908; Email: sunxilin@aliyun.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150028
      • Recruiting
      • Department of Nuclear Medicine, Fourth Affiliated Hospital of Harbin Medical University
      • Contact: Xilin Sun, MD; Phone Number: +86-15904601908; Email: sunxilin@aliyun.com
      • Contact: Xilin Sun, MD
      • Contact: Zhaoguo Han, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: 18F-TSPF; Each subject receives interval imaging of 18F-TSPF PET/CT and 18F-FDG PET/CT.	Diagnostic test: 18F-TSPF PET/CT; Each subject receives interval imaging of 18F-TSPF PET/CT and 18F-FDG PET/CT, and further follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized Uptake Values	To quantify the PET, a volume of interest using a 3-D sphere, was placed over the primary lung tumor, lymph nodes and distant metastases avoiding necrosis, blood vessels and normal lung tissue as much as possible on a workstation (Advantage Workstation 4.6; GE Healthcare). The maximum standard uptake value (SUVmax) normalized to body weight (kBq/mL) was calculated within the region of interest. SUVmax of primary lesion and metastatic lesion in subjects with NSCLC are measured and used to analyze correlatation with pathology or gene detection.	1 hour

Collaborators and Investigators

• Sponsor: Xilin Sun
• Collaborators: Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Actual): March 28, 2025
• Study Completion (Estimated): June 28, 2025

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2023-LLSC-23 (Other Identifier: HarbinMU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Xilin Sun
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No