Evaluating FAPI PET/CT for Diagnosing FAP-Related Diseases
FAPI PET/CT in Various FAP-Related Disease Patients
This study is testing if a special type of scan can help find cancer in adults who have or might have tumors related to FAP.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06688071 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of 68Ga/18F-FAPI positron emission tomography/computed tomography (PET/CT) in identifying primary and metastatic lesions in patients with various FAP-related diseases. Participants, who are adults with suspected or diagnosed malignant tumors, will undergo FAPI PET/CT scans either for initial evaluation or to detect recurrence. The study will quantify lesion uptake and calculate key diagnostic metrics such as sensitivity, specificity, and accuracy to determine the utility of this imaging technique.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 or older with suspected or diagnosed malignant tumors.
Not a fit: Patients with non-malignant lesions or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy for patients with FAP-related diseases, leading to better treatment planning.
How similar studies have performed: While the use of PET/CT imaging is established, the specific application of 68Ga/18F-FAPI in FAP-related diseases is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled FAPI PET/CT scan; (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 lesions; (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
Tianjin, Tianjin Municipality
- Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Haonan Yu, MD
- Email: dreamadam@126.com
- Phone: +8613821000597
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.