abdominal aortic aneurysm
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 40 years, no gender restrictions. 2. Patients with imaging-confirmed abdominal aortic dilatation or abdominal aortic aneurysm, with a maximum outer diameter exceeding 1.5 times the normal vessel diameter, or small AAA with a maximum outer diameter of 2.6–5.0 cm. 3. At least one follow-up imaging study (CT/CTA or ultrasound) after 68Ga-FAPI PET/CT examination. 4. Able to understand and sign a written informed consent form. 5. Expected to comply with and complete follow-up (minimum 24 months).
Exclusion criteria
Exclusion criteria: 1. Patients with prior abdominal aortic repair/stent graft placement. 2. Patients with acute symptomatic ruptured abdominal aortic aneurysm. 3. Patients with hereditary or inflammatory aortic diseases (e.g., Marfan syndrome, Loeys-Dietz syndrome, giant cell arteritis, giant cell aneurysm, infectious aneurysm, etc.). 4. Patients with severe renal impairment (eGFR < 30 ml/min) or those at high risk for contrast agent administration. 5. Pregnant or lactating women, or subjects planning pregnancy. 6. Subjects with a history of severe allergy to the study tracer or formulation, or those unable to undergo radiological examinations. 7. Subjects with an expected survival period <12 months. 8. Subjects unable to complete the PET/CT scan as required (e.g., due to severe psychiatric disorders, inability to cooperate, etc.). 9. Subjects currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual growth rate of abdominal aortic aneurysm diameter (mm/year);Clinical composite adverse events;Baseline FAPI uptake level in the abdominal aortic aneurysm wall; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in 68Ga-FAPI uptake parameters at 1 year;FAPI uptake values in non-aneurysmal aortic segments in patients with small AAA;All-cause mortality and AAA-related mortality in patients with small AAA during the follow-up period;Relationship between preoperative FAPI uptake and postoperative outcomes after EVAR; | — |
Countries
China
Contacts
First Medical Center, PLA General Hospital