PET Imaging of MMP Activation in AAA: Clinical Component (PET AAA)

March 16, 2026 updated by: Washington University School of Medicine
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Contact:
          • Robert Gropler, MD
          • Phone Number: 314-747-0183
        • Principal Investigator:
          • Robert Gropler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: dosimetry and AAA patients
Patients who have abdominal aortic aneurysm and healthy volunteers
Drug: Cu-64-RYM2
PET/CT scan
Drug: PET imaging using Cu-64
PET/CT at different timepoints

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Verification Cu-64RYM-2 signal is present in AAA segment of the abdominal aorta
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cu-64RYM-2 signal is higher
Time Frame: 2 years
MMP activity will be higher in AAA patients than in healthy volunteers
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Robert Gropler, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202505027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only de-identified images will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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