PET scan to image MMP activity in abdominal aortic aneurysm
PET Imaging of MMP Activation in AAA: Clinical Component
We will test whether a new PET tracer ([64Cu]-RYM2) can safely image MMP activity in people with abdominal aortic aneurysm and in healthy volunteers.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07473102 on ClinicalTrials.gov |
What this trial studies
This first-in-human protocol administers [64Cu]-RYM2 followed by PET/CT to characterize safety, biodistribution, and radiation dosimetry in healthy volunteers. In patients with abdominal aortic aneurysm who undergo surgical repair, preoperative PET imaging will be used to study tracer pharmacodynamics and imaging features will be compared with ex vivo measurements from resected aneurysm tissue. Imaging sessions require participants to lie supine in the PET/CT scanner for about one hour and to follow breathing instructions during the CT portion. The primary goals are to establish safety, dosimetry, and imaging-to-tissue correlation rather than to provide therapeutic benefit.
Who should consider this trial
Good fit: Ideal candidates are adults with a diagnosed abdominal aortic aneurysm who are scheduled for surgical repair, and separate healthy volunteers who meet the imaging inclusion criteria.
Not a fit: People who are pregnant or breastfeeding, have severe renal impairment (GFR <30 mL/min/1.73 m2), cannot lie still in a scanner or have claustrophobia, or exceed the BMI limit are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the tracer could enable noninvasive detection of MMP activity in AAAs and help identify aneurysms at higher risk of growth or rupture to better guide timing of intervention.
How similar studies have performed: This is the first human use of [64Cu]-RYM2, while related molecular PET approaches for imaging protease activity have shown promising preclinical results but limited clinical data to date.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Robert Gropler, MD — Washington University School of Medicine
- Study coordinator: Kitty Harrison, RN, BSN
- Email: kittydharrison@wustl.edu
- Phone: 314-747-0183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.