PET Imaging for Abdominal Aortic Aneurysm

(PET AAA Trial)

Overseen By Robert Gropler, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Washington University School of Medicine

Must be taking: Antihypertensives, Statins

Must not be taking: Recreational drugs

Disqualifiers: Pregnancy, Chronic renal disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Robert Gropler, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

* 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Dosimetry Assessment

Participants undergo PET/CT imaging to assess safety, biodistribution, and radiation dosimetry of [64Cu]-RYM2

1-2 weeks

1 visit (in-person)

Surgical Evaluation

AAA patients undergo surgery and radiotracer pharmacodynamics are evaluated, correlating PET imaging with ex vivo tissue measurements

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and surgical procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cu-64-RYM2

How Is the Trial Designed?

Group I: dosimetry and AAA patients Experimental Treatment 2 Interventions

Patients who have abdominal aortic aneurysm and healthy volunteers

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+