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A first-in-human evaluation of [64Cu]-RYM2 with PET/CT will be performed to: a) assess its safety, biodistribution, and radiation dosimetry in normal volunteers (WU) and; b) in AAA patients undergoing surgery (WU and Yale), evaluate radiotracer pharmacodynamics and correlate PET imaging characteristics (WU) with ex vivo tissue measurements (Yale).
A first-in-human evaluation of [64Cu]-RYM2 with PET/CT will be performed to: a) assess its safety, biodistribution, and radiation dosimetry in normal volunteers (WU) and; b) in AAA patients undergoing surgery (WU and Yale), evaluate radiotracer pharmacodynamics and correlate PET imaging characteristics (WU) with ex vivo tissue measurements (Yale).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dosimetry and AAA patients | Other | Patients who have abdominal aortic aneurysm and healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cu-64-RYM2 | Drug | PET/CT scan |
| |
| PET imaging using Cu-64 |
| Measure | Description | Time Frame |
|---|---|---|
| Verification Cu-64RYM2-2 signal in AAA segments. This will be performed by measuring Standard Uptake Values obtained from analysis of the Cu-64RYM2 images, in AAA patients. | Verification Cu-64RYM-2 signal is present in AAA segment of the abdominal aorta | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cu-64RYM-2 signal is higher | MMP activity will be higher in AAA patients than in healthy volunteers | 2 years |
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Inclusion Criteria: Healthy Volunteers
Exclusion Criteria: Healthy Volunteers
Inclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair
Exclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kitty Harrison, RN, BSN | Contact | 314-747-0183 | kittydharrison@wustl.edu | |
| Robert Gropler, MD | Contact | 314-747-0183 | rgropler@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert Gropler, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18936327 | Background | Zhang J, Nie L, Razavian M, Ahmed M, Dobrucki LW, Asadi A, Edwards DS, Azure M, Sinusas AJ, Sadeghi MM. Molecular imaging of activated matrix metalloproteinases in vascular remodeling. Circulation. 2008 Nov 4;118(19):1953-60. doi: 10.1161/CIRCULATIONAHA.108.789743. Epub 2008 Oct 20. | |
| 26352243 | Background | Davis FM, Rateri DL, Daugherty A. Abdominal aortic aneurysm: novel mechanisms and therapies. Curr Opin Cardiol. 2015 Nov;30(6):566-73. doi: 10.1097/HCO.0000000000000216. |
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Only de-identified images will be shared
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Drug |
PET/CT at different timepoints |
|
| 27903546 | Background | Curci JA, Beckman JA. Positron Emission Tomography Fluorine-18-Labeled 2-Deoxy-2-Fluoro-d-Glucose Tells a Complicated Story in the Aortic Aneurysm Wall. Circ Cardiovasc Imaging. 2016 Nov;9(11):e005689. doi: 10.1161/CIRCIMAGING.116.005689. No abstract available. |
| 24381115 | Background | Golestani R, Sadeghi MM. Emergence of molecular imaging of aortic aneurysm: implications for risk stratification and management. J Nucl Cardiol. 2014 Apr;21(2):251-67; quiz 268-70. doi: 10.1007/s12350-013-9845-5. Epub 2014 Jan 1. |
| 25427112 | Background | Kent KC. Clinical practice. Abdominal aortic aneurysms. N Engl J Med. 2014 Nov 27;371(22):2101-8. doi: 10.1056/NEJMcp1401430. No abstract available. |
| 25060754 | Background | Davis FM, Rateri DL, Daugherty A. Mechanisms of aortic aneurysm formation: translating preclinical studies into clinical therapies. Heart. 2014 Oct;100(19):1498-505. doi: 10.1136/heartjnl-2014-305648. Epub 2014 Jul 24. |
| 26763279 | Background | Toczek J, Meadows JL, Sadeghi MM. Novel Molecular Imaging Approaches to Abdominal Aortic Aneurysm Risk Stratification. Circ Cardiovasc Imaging. 2016 Jan;9(1):e003023. doi: 10.1161/CIRCIMAGING.115.003023. |
| D001018 |
| Aortic Diseases |