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NCT Number: NCT06911697

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Harbin, Heilongjiang, 150028, China

Location status: Recruiting

Location contact

Xilin Sun, MD

CONTACT

[email protected]

+86-15904601908

Xilin Sun, MD

PRINCIPAL_INVESTIGATOR

Zhaoguo Han, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Standardized Uptake Values

    Time frame: 1 hour

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xilin Sun, MD

CONTACT

[email protected]

+86-15904601908

Sponsors and collaborators

Lead sponsor

Xilin Sun

Other

Collaborators

  • Henan Provincial People's Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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