NCT07473102 · Washington University School of Medicine
PET Imaging of MMP Activation in AAA: Clinical Component
(PET AAA)
What this study is about
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 how the drug affects the body and correlate PET imaging characteristics (WU) with ex vivo tissue measurements (Yale).
View original scientific 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
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.
Where
- St Louis, Missouri
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2026 · Source of record for eligibility and locations