Imaging with a new PET agent for SSTR2 positive diseases
68Ga-FAPI-LM3 PET/CT Imaging in Patients With FAP/SSTR2 Positive Disease and Compared With 18F-FDG
This study is testing a new imaging agent to see if it can provide better results for patients with SSTR2 positive diseases compared to the current standard imaging method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT05873777 on ClinicalTrials.gov |
What this trial studies
This research investigates the safety and effectiveness of a new dual receptor targeting PET radiotracer, 68Ga-FAPI-LM3, in patients with SSTR2 positive diseases. Participants will undergo both 68Ga-FAPI-LM3 and 18F-FDG PET/CT scans to assess the diagnostic accuracy of the new imaging agent compared to the standard. The study will evaluate biodistribution, radiation dosimetry, and the number of detected lesions. The goal is to determine if 68Ga-FAPI-LM3 provides better imaging results for these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults with suspected or newly diagnosed malignant diseases that express FAP or SSTR2.
Not a fit: Patients with non-malignant diseases or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing SSTR2 positive diseases, leading to better patient management.
How similar studies have performed: While the use of PET imaging is well-established, the specific application of 68Ga-FAPI-LM3 for SSTR2 positive diseases is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (i) adult patients (aged 18 years or order); * (ii) patients with suspected or newly diagnosed or previously malignant disease, with either FAP or SSTR2 positive expression (supporting evidence may include MRI, CT, and pathology report etc); * (iii) patients who had scheduled both 18F-FDG and 68Ga-FAPI-LM3 PET/CT scans; * (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: * (i) patients with non-malignant disease; * (ii) patients with pregnancy; * (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Where this trial is running
Xiamen, Fujian
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Long Sun, PhD
- Email: 13178352662@163.com
- Phone: 86 0592-2137077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.