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

NCT06911697 | Recruiting DMC

• 1 other identifier: 2023-LLSC-23
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

PET/CT Imaging; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Experimental: 18F-TSPF

EXPERIMENTAL

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

Diagnostic Test: 18F-TSPF PET/CT

Interventions

18F-TSPF PET/CT DIAGNOSTIC_TEST

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

Experimental: 18F-TSPF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range 18-75 years, open to both male and female participants;
• Normal hepatic/renal function and cardiac function;
• Expected survival of at least 12 weeks;
• Good adherence to follow-up;
• Presence of at least one measurable target lesion according to RECIST 1.1 criteria;
• 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;
• Patients for whom a clinical physician recommends PET/CT scans for the diagnosis and staging of tumors;
• Participants must fully understand and voluntarily agree to participate in the study, and must sign an informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Xilin Sun: lead
• Henan Provincial People's Hospital: collaborator

Study Sites (1)

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

Harbin, Heilongjiang, 150028, China

RECRUITING

Central Study Contacts

Xilin Sun, MD

CONTACT

+86-15904601908; sunxilin@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: October 26, 2023
• Primary Completion: March 28, 2025
• Study Completion: June 28, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)