Study on c-Met Targeted PET/CT Imaging in NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-TSPF PET/CT.
- Who it may be relevant to
- Registry conditions: PET/CT Imaging, NSCLC. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
In Vivo Detection of c-Met Activation Status by Specific PET/CT Imaging Based on 18F Labeled Small Molecule TKI
Overview
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.
Interventions
- 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.
Primary outcome measures
- Standardized Uptake Values [Time frame: 1 hour]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Department of Nuclear Medicine, Fourth Affiliated Hospital of Harbin Medical University — Harbin
Identifiers
NCT: NCT06911697 · 2023-LLSC-23 · 2023-LLSC-23