Actively Recruiting
In Vivo Detection of c-Met Activation Status by Specific PET/CT Imaging Based on 18F Labeled Small Molecule TKI
Led by Xilin Sun · Updated on 2025-04-04
88
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
X
Xilin Sun
Lead Sponsor
H
Henan Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging method using an 18F labeled small molecule called 18F-TSPF, designed to detect c-Met activation status in patients with non-small cell lung cancer (NSCLC). The study focuses on patients with various c-Met activation types confirmed by pathology or gene testing, aiming to assess the ability of this novel PET radiotracer to accurately identify c-Met activity and potentially select patients who may benefit from c-Met tyrosine kinase inhibitors (TKIs). Participants will undergo two types of PET/CT scans: 18F-TSPF PET/CT and 18F-FDG PET/CT, performed at intervals. These imaging tests are designed to compare the specificity and accuracy of 18F-TSPF in detecting c-Met activation. The study includes follow-up assessments after the imaging procedures to monitor results and patient status. During the study, participants will receive PET/CT scans and be evaluated using standardized uptake values measured one hour after tracer administration. Researchers will assess imaging results alongside clinical data to determine the tracer's effectiveness. Participants must adhere to follow-up schedules and meet safety requirements, including normal organ function and ability to lie flat during scans. The total participation period varies depending on follow-up needs, with safety and imaging accuracy closely monitored throughout the trial.
CONDITIONS
Brief Title
Study on c-Met Targeted PET/CT Imaging in NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Normal liver, kidney, and heart function
- Expected survival of at least 12 weeks
- Ability to adhere to follow-up visits
- At least one measurable target lesion following RECIST 1.1 criteria
- Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before study start
- Agree to use effective contraception during the study and for 3 months after final exam if sexually active
- Recommended for PET/CT scans by a clinical physician for tumor diagnosis and staging
- Understand and voluntarily agree to participate, signing informed consent
You will not qualify if you...
- Severe liver or kidney function abnormalities or blood count issues
- Planning to conceive
- Pregnant or breastfeeding women
- Unable to lie flat for 30 minutes
- Refusal to participate in the study
- Claustrophobia or psychiatric disorders
- Other conditions making participation unsuitable as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive interval imaging of 18F-TSPF PET/CT and 18F-FDG PET/CT to detect c-Met activation status.
2 imaging visits (in-person)
Duration - Up to 12 weeks
Participants undergo follow-up assessments to evaluate the imaging outcomes over time.
Follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Department of Nuclear Medicine, Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150028
Actively Recruiting
Research Team
X
Xilin Sun, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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