NCT07473102 PET Imaging of MMP Activation in AAA: Clinical Component
| NCT ID | NCT07473102 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Washington University School of Medicine |
| Condition | Abdominal Aortic Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 28 participants in total. It began in 2025-11-03 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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 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.
Contact & Investigator
Robert Gropler, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT07473102 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Abdominal Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07473102 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07473102 currently recruiting?
Yes, NCT07473102 is actively recruiting participants. Contact the research team at kittydharrison@wustl.edu for enrollment information.
Where is the NCT07473102 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT07473102 clinical trial?
NCT07473102 is sponsored by Washington University School of Medicine. The principal investigator is Robert Gropler, MD at Washington University School of Medicine. The trial plans to enroll 28 participants.