PET scan tracer for abdominal aortic aneurysm in volunteers and patients
Tests a new PET scan tracer in healthy volunteers and aneurysm surgery patients.
Key facts
- Who runs it
- Washington University School of Medicine
- Where
- St Louis, United StatesSee the site
- Trial code
- Registry title
- PET Imaging of MMP Activation in AAA: Clinical Component
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 28 people, planned
- Started
- 3 Nov 2025
- Expected to end
- 31 Mar 2027
- Type of study
- Interventional
- Treatments tested
- Cu-64-RYM2
- PET imaging using Cu-64
- Record updated
- 18 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy volunteers and for people with an abdominal aortic aneurysm (a bulge in the main belly artery) who are planned for surgery. It tests a new PET/CT scan tracer, [64Cu]-RYM2.
- Age
- Healthy volunteers: 18 years and older. Patients with aneurysm: 40-80 years.
- Sex
- Men and women can join.
- Disease stage
- Patients: an abdominal aortic aneurysm planned for surgical repair. The size is 5.0 cm (2 in) (women) to 5.5 cm (2.2 in) (men), or larger than 5.5 or 6.0 cm (2.2–2.4 in), or growing fast (more than 0.5 cm (0.2 in) in 6 months or more than 1 cm (0.4 in) in 12 months). Patients must have high blood pressure and high blood fats treated with medicine. Healthy volunteers must have no known heart, lung, liver or kidney disease or diabetes, and a BMI of 40 or less.
- Earlier treatment
- Healthy volunteers cannot join if they had a study in the last year with test radiotracers or CT that would affect results or give too much radiation.
Main reasons for not taking part
- Pregnant or breastfeeding.
- Severe chronic kidney disease with GFR less than 30 mL/min/1.73 m2.
- Fear of closed spaces, or unable to lie still on the back for about 60 minutes.
- Patients: allergy to iodine contrast dye or shellfish, recently treated heart disease, cancer under treatment, or autoimmune or inflammatory disease.
- Healthy volunteers: body weight over 300 lbs (136 kg), recreational drug use, or taking part in another study with a test drug.
The registry criteria, word for word
Show all 29 criteriaShow less
Who can take part
- 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
- 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
Who cannot take part
- Currently using recreational drugs
- 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
- Currently enrolled in another study using an investigational drug
- Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study
- 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
- 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
- Patient with chronic renal disease whose glomerular filtration rate (GFR) is less than 30 mL/min/1.73 m2
- Patient with chronic renal disease whose GFR is less than 30 mL/min/1.73 m2
- Inability to receive and sign informed consent
- Pregnant (confirmed by urine pregnancy test) and/or breastfeeding
- 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)
- Body weight of >300 lbs. (weight limit of the PET table)
- Inability to receive and sign informed consent
- Pregnant (confirmed by urine pregnancy test) and/or breastfeeding
- Inability to tolerate 60 minutes in a supine position with arms down at sides, as necessary for PET/CT
Where in United States
- Washington University School of MedicineSt Louis, United StatesContact: Kitty Harrison, RN, BSNTaking people
About the trial
What the trial wants to find out
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).
The group in the trial
- dosimetry and AAA patientsOther group
Patients who have abdominal aortic aneurysm and healthy volunteers
Treatment: Cu-64-RYM2 and PET imaging using Cu-64
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- PET Imaging of MMP Activation in AAA: Clinical Component
- Plain-language title
- PET scan tracer for abdominal aortic aneurysm in volunteers and patientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 18 March 2026