Evaluating FAPI PET/CT for Diagnosing FAP-Related Diseases
Official title: FAPI PET/CT in Various FAP-Related Disease Patients
Run by Tianjin Medical University · NCT06688071 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Tianjin Medical University Academic / other |
| Locations | 3 sites (Hefei, Anhui and 2 other locations) |
| Status | Recruiting |
| Started | March 1, 2022 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT06688071 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients aged 18 or older with suspected or diagnosed malignant tumors.
✕Probably not a fit
Patients with non-malignant lesions or those who are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China Recruiting -
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China Recruiting -
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: Haonan Yu, MD
- Email: dreamadam@126.com
- Phone: +8613821000597
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.