Recruiting
Early Phase 1

[64Cu]-RYM2

Sponsor:

Washington University School of Medicine

Code:

NCT07473102

Conditions

Abdominal Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cu-64-RYM2

PET imaging using Cu-64

Study Details

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).

Conditions

Abdominal Aortic Aneurysm

Study ID

NCT07473102

Start date

Nov 3, 2025

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

28 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: dosimetry and AAA patients

Patients who have abdominal aortic aneurysm and healthy volunteers

Interventions

Cu-64-RYM2

PET/CT scan

PET imaging using Cu-64

PET/CT at different timepoints

Primary outcome measure

  • Verification Cu-64RYM2-2 signal in AAA segments. This will be performed by measuring Standard Uptake Values obtained from analysis of the Cu-64RYM2 images, in AAA patients. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Robert Gropler, MD

314-747-0183

Principal Investigator:

Robert Gropler, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • Imaging for Aneurysm Abdominal
  • Imaging for Abdominal Aneurysms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-03-18.