PET Imaging of MMP Activation in AAA: Clinical Component
Recruiting
Early Phase 1Interventional Study
Abdominal Aortic Aneurysm
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
28 (estimated)
Sponsor
Washington University School of Medicine · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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Status
Eligibility Criteria
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 pr…
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.
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