Pan-amyloid PET/CT scans to find amyloid deposits in adults
Pan-Amyloid PET/CT in Various Amyloid-Related Disease
This project tests whether PET/CT scans using amyloid tracers can find amyloid deposits in adults with suspected or known amyloidosis, including heart involvement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Academic / other |
| Locations | 2 sites (Hefei, Anhui and 1 other locations) |
| Trial ID | NCT07130565 on ClinicalTrials.gov |
What this trial studies
This observational imaging effort uses several amyloid PET tracers (including 18F-labeled ligands and 11C-PIB) to image adults with suspected, newly diagnosed, or previously treated amyloidosis. Participants undergo PET/CT (and where available MRI) for initial staging or detection of recurrence, and focal uptake is quantified by SUVmax. The team will calculate sensitivity, specificity, positive and negative predictive values, and overall accuracy of tracer uptake for identifying primary and metastatic amyloid lesions. Imaging is conducted at tertiary centers in China and data are analyzed to characterize diagnostic performance across lesion sites.
Who should consider this trial
Good fit: Adults (18+) with suspected, newly diagnosed, or previously treated amyloidosis who are scheduled for a pan-amyloid PET/CT scan and can provide informed consent are ideal candidates.
Not a fit: People who do not have amyloid-related disease, who are pregnant, or who cannot undergo or consent to PET/CT imaging are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could help doctors detect and map amyloid deposits throughout the body more accurately, which may guide diagnosis and management.
How similar studies have performed: Previous work with tracers like 11C-PIB and various 18F amyloid ligands has shown promising detection of cerebral and cardiac amyloid, but whole-body (pan-amyloid) imaging is a relatively newer application with mixed but encouraging results.
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 cardiac amyloidosis (supporting evidence may include MRI, CT, serum markers and pathology report); (iii) patients who had scheduled Pan-Amyloid 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-CA 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
Hefei, Anhui and 1 other locations
- The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, 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
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.