PET/CT ImagingNCT06911697
Study on c-Met Targeted PET/CT Imaging in NSCLC
A study testing 18F-TSPF PET/CT in people with PET/CT Imaging and NSCLC, run by Xilin Sun at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- PET/CT Imaging, NSCLC
- What is being tested?
- 18F-TSPF PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2023to 28 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150028
Xilin Sun, MD, +86-15904601908, sunxilin@aliyun.com
Xilin Sun, MD
About this study
Official title: In Vivo Detection of c-Met Activation Status by Specific PET/CT Imaging Based on 18F Labeled Small Molecule TKI
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.
Read the 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.
- Conditions
- PET/CT Imaging, NSCLC
- Being tested
- 18F-TSPF PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-TSPF PET/CTDiagnostic test
Each subject receives interval imaging of 18F-TSPF PET/CT and 18F-FDG PET/CT, and further follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 18F-TSPF | Experimental | Each subject receives interval imaging of 18F-TSPF PET/CT and 18F-FDG PET/CT. Receives: Diagnostic Test: 18F-TSPF PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start26 Oct 2023
- Primary completion28 Mar 2025
- Study completion28 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PET/CT ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xilin Sun
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Xilin Sun, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911697
- Sponsor's protocol ID
- 2023-LLSC-23
- Other IDs
- 2023-LLSC-23
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Xilin Sun
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Detection of c-Met Activation Status by Specific PET/CT Imaging Based on 18F Labeled Small Molecule TKI
- ClinicalTrials.gov ID
- NCT06911697
- Acronym / sponsor ID
- 2023-LLSC-23
- Conditions
- PET/CT Imaging, NSCLC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Xilin SunUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: 18F-TSPF | Experimental | Diagnostic Test: 18F-TSPF PET/CTEach subject receives interval imaging of 18F-TSPF PET/CT and 18F-FDG PET/CT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-TSPF PET/CTEach subject receives interval imaging of 18F-TSPF PET/CT and 18F-FDG PET/CT, and further follow-up. | Diagnostic test | Experimental: 18F-TSPF |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Yes. Xilin Sun
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-TSPF PET/CT in people with PET/CT Imaging and NSCLC, run by Xilin Sun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xilin Sun, MD (+86-15904601908, sunxilin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Uptake Values (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.