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| ID | Type | Description | Link |
|---|---|---|---|
| UPENN IRB# 25-0899 (858617) | Other Identifier | UPENN |
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This research study is being conducted to test how an imaging drug called 64Cu-DOTA-ECL1i can be used to image an abdominal aortic aneurysm. 64Cu-DOTA-ECL1i is a drug used with an imaging test called a PET/CT (Positron Emission Tomography/Computed Tomography).
The aim is to collect data using a new imaging drug called 64Cu-DOTA-ECL1i that may be able to create images of inflammation in the aorta, which is thought to be important in how aneurysms grow and develop and to understand how consistent these scans are across time and what might affect the inflammation.
Abdominal aortic aneurysm (AAA) is a life-threatening condition in which progressive dilatation of the infrarenal aorta leads to rupture. With ~2.3 million prevalent cases, AAA afflicts ~4% of the U.S. population ≥ 65 years of age and is responsible for ~41,000 deaths annually 4,5. No pharmacologic therapies exist that prevent AAA development, growth, rupture, or aneurysm-related deaths. No diagnostic approaches exist to predict which AAAs will grow and eventually rupture.
The study will use the radiotracer 64Cu-DOTA-ECL1i to assess the aortic wall in individuals with AAA and repeat these exams approximately 6-8 weeks after baseline to evaluate longitudinal biological variation in uptake and the impact of any clinical changes or treatment effects on tracer uptake. These data will provide insight into molecular imaging of AAA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants diagnosed with Abdominal Aortic Aneurysm (AAA) | Established diagnosis of abdominal aortic aneurysm based on standard clinical criteria. |
| |
| Control Group | Age-matched participants without a diagnosis of AAA as a control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 64Cu-DOTA-ECL1i | Drug | The radiotracer 64Cu-DOTA-ECL1i will be used to assess the aortic wall in individuals with AAA and age-matched participants without a diagnosis of AAA as a control group. |
| Measure | Description | Time Frame |
|---|---|---|
| • Measure uptake of 64Cu-DOTA-ECL1 | • Measure uptake of 64Cu-DOTA-ECL1i in patients with abdominal aortic aneurysm at two time points to evaluate intra-individual variability of radiotracer uptake | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing 64Cu-DOTA-ECL1i uptake | • Compare 64Cu-DOTA-ECL1i uptake between AAA and control individuals. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate uptake of 64Cu-DOTA-ECL1i | Correlate uptake of 64Cu-DOTA-ECL1i in the aortic wall with morphologic features on CTA. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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We plan to enroll up to 15 fully evaluable adult participants in this pilot study who have an established diagnosis of AAA and up to 5 fully evaluable adult participants who do not have a diagnosis of AAA.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Schubert | Contact | 215-573-6569 | erin.schubert@pennmedicine.upenn.edu | |
| Mary Hansbury | Contact | 215-746-8192 | mary.hansbury@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Scott M Damrauer, MD | Penn Medicine Division of Vascular Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine; Perelman School of Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
This is an internal study and there are no plans to share data.
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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Blood samples will be taken at various time points to measure the concentration of the imaging drug in the blood during the scan. Participants will provide a total of approximately 20 mL of blood on the day of each PET/CT scan i.e., a total blood volume of approximately 40 mL (less than 3 tablespoons)