In Vivo Detection of c-Met Activation Status by Specific PET/CT Imaging Based on 18F Labeled Small Molecule TKI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Standardized Uptake Values
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Experimental: 18F-TSPF
Each subject receives interval imaging of 18F-TSPF PET/CT and 18F-FDG PET/CT.
Intervention: 18F-TSPF PET/CT (Diagnostic Test)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Xilin Sun
Director
Harbin Medical University