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Clinical Trial NCT06911697 for PET/CT Imaging, NSCLC is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Study on c-Met Targeted PET/CT Imaging in NSCLC 88

Recruiting
Clinical Trial NCT06911697 is an interventional study for PET/CT Imaging, NSCLC that is recruiting. It started on 26 October 2023 with plans to enroll 88 participants. Led by Xilin Sun, it is expected to complete by 28 June 2025. The latest data from ClinicalTrials.gov was last updated on 4 April 2025.
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...Show More
Official Title

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

Conditions
PET/CT ImagingNSCLC
Other Study IDs
  • 2023-LLSC-23
  • 2023-LLSC-23 (Other Identifier) (HarbinMU)
NCT ID Number
NCT06911697
Start Date (Actual)
2023-10-26
Last Update Posted
2025-04-04
Completion Date (Estimated)
2025-06-28
Enrollment (Estimated)
88
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalExperimental: 18F-TSPF
Each subject receives interval imaging of 18F-TSPF PET/CT and 18F-FDG PET/CT.
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
Outcome MeasureMeasure DescriptionTime Frame
Standardized Uptake Values
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.
1 hour
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  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.

  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.
Xilin Sun logoXilin Sun
Henan Provincial People's Hospital logoHenan Provincial People's Hospital
Study Responsible Party
Xilin Sun, Sponsor-Investigator, Director, Harbin Medical University
Study Central Contact
Contact: Xilin Sun, MD, +86-15904601908, [email protected]
1 Study Locations in 1 Countries

Heilongjiang

Department of Nuclear Medicine, Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150028, China
Xilin Sun, MD, Contact, +86-15904601908, [email protected]
Xilin Sun, MD, Principal Investigator
Zhaoguo Han, MD, Sub-Investigator
Recruiting