NSCLC, PET/CT Imaging
Conditions
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.
Interventions
DIAGNOSTIC_TEST18F-TSPF PET/CT
Each subject receives interval imaging of 18F-TSPF PET/CT and 18F-FDG PET/CT, and further follow-up.
Sponsors
Henan Provincial People's Hospital
Xilin Sun
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Uptake Values | 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. |
Countries
China
Contacts
Primary ContactXilin Sun, MD
Outcome results
None listed