PET Imaging of MMP Activation in AAA: Clinical Component
Purpose
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).
Condition
- Abdominal Aortic Aneurysm
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
Healthy Volunteers - No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions. - Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol. - Capable of lying still and supine within the PET/CT scanner for ~1 hour and follow instructions for breathing protocol during the CT portion. - No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year. - No known history of cardiac, pulmonary, hepatic or renal disease or diabetes - BMI ≤ 40
Exclusion Criteria
Healthy Volunteers - Inability to receive and sign informed consent; - Pregnant (confirmed by urine pregnancy test) and/or breastfeeding - Patient with chronic renal disease whose glomerular filtration rate (GFR) is less than 30 mL/min/1.73 m2 - Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study. - Is deemed likely to be unable to perform all research procedures for any reason, (e.g., subjects unable to lie still or inability to tolerate up to 60 minutes in a supine position with arms up during the PET imaging procedures due to chronic back/shoulder pain or arthritis as assessed by physical examination and medical history). - Currently using recreational drugs. - Body weight of >300 lbs. (weight limit of the PET table). - Currently enrolled in another study using an investigational drug or underwent a study the last year involving investigational use of radiotracers or CT would confound results or with a radiation exposure when combined with this study would be deemed as excessive by the Sponsor-Investigator. Inclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair - Men or women 40-80 years of age - Willing and able to provide informed consent - Medically managed hypertension and hyperlipidemia - No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions - Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol - Patients with AAA indicated for surgical repair (5.0 [female] - 5.5cm [male]), incidentally identified large(r) AAAs (>5.5 or 6.0 cm), and rapidly expanding AAAs (> 0.5 cm in 6 months or > 1 cm in 12 months) per Guidelines of the Society for Vascular Surgery. Exclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair - Inability to receive and sign informed consent. - Currently enrolled in another study using an investigational drug - Pregnant (confirmed by urine pregnancy test) and/or breastfeeding - Patient with chronic renal disease whose GFR is less than 30 mL/min/1.73 m2 - Documented allergy to iodinated contrast and/or shellfish - Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study. - Inability to tolerate 60 minutes in a supine position with arms down at sides, as necessary for PET/CT. - Other conditions such as symptomatic/recently treated coronary disease, cancer requiring oncologic management, or autoimmune/inflammatory diseases (e.g., rheumatoid arthritis or multiple sclerosis). - Non-AAA volunteers may not carry a diagnosis of aortoiliac occlusive disease, as documented by their treating vascular surgeon, as significantly progressed atherosclerotic disease may demonstrate exaggerated, associated MMP activity.
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other dosimetry and AAA patients |
Patients who have abdominal aortic aneurysm and healthy volunteers |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis, Missouri 63110
More Details
- NCT ID
- NCT07473102
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine
Detailed Description
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).