PET Imaging of MMP Activation in AAA: Clinical Component

NCT07473102 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 202505027
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Keywords

Imaging for Aneurysm Abdominal; Imaging for Abdominal Aneurysms

Outcome Measures

Primary Outcomes (1)

• 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.

  Verification Cu-64RYM-2 signal is present in AAA segment of the abdominal aorta

  2 years

Secondary Outcomes (1)

• Cu-64RYM-2 signal is higher

  2 years

Study Arms (1)

dosimetry and AAA patients

OTHER

Patients who have abdominal aortic aneurysm and healthy volunteers

Drug: Cu-64-RYM2; Drug: PET imaging using Cu-64

Interventions

Cu-64-RYM2 DRUG

PET/CT scan

dosimetry and AAA patients

PET imaging using Cu-64 DRUG

PET/CT at different timepoints

dosimetry and AAA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• Inability to receive and sign informed consent.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (7)

• Zhang J, Nie L, Razavian M, Ahmed M, Dobrucki LW, Asadi A, Edwards DS, Azure M, Sinusas AJ, Sadeghi MM. Molecular imaging of activated matrix metalloproteinases in vascular remodeling. Circulation. 2008 Nov 4;118(19):1953-60. doi: 10.1161/CIRCULATIONAHA.108.789743. Epub 2008 Oct 20.

  PMID: 18936327 BACKGROUND

• Davis FM, Rateri DL, Daugherty A. Abdominal aortic aneurysm: novel mechanisms and therapies. Curr Opin Cardiol. 2015 Nov;30(6):566-73. doi: 10.1097/HCO.0000000000000216.

  PMID: 26352243 BACKGROUND

• Curci JA, Beckman JA. Positron Emission Tomography Fluorine-18-Labeled 2-Deoxy-2-Fluoro-d-Glucose Tells a Complicated Story in the Aortic Aneurysm Wall. Circ Cardiovasc Imaging. 2016 Nov;9(11):e005689. doi: 10.1161/CIRCIMAGING.116.005689. No abstract available.

  PMID: 27903546 BACKGROUND

• Golestani R, Sadeghi MM. Emergence of molecular imaging of aortic aneurysm: implications for risk stratification and management. J Nucl Cardiol. 2014 Apr;21(2):251-67; quiz 268-70. doi: 10.1007/s12350-013-9845-5. Epub 2014 Jan 1.

  PMID: 24381115 BACKGROUND

• Kent KC. Clinical practice. Abdominal aortic aneurysms. N Engl J Med. 2014 Nov 27;371(22):2101-8. doi: 10.1056/NEJMcp1401430. No abstract available.

  PMID: 25427112 BACKGROUND

• Davis FM, Rateri DL, Daugherty A. Mechanisms of aortic aneurysm formation: translating preclinical studies into clinical therapies. Heart. 2014 Oct;100(19):1498-505. doi: 10.1136/heartjnl-2014-305648. Epub 2014 Jul 24.

  PMID: 25060754 BACKGROUND

• Toczek J, Meadows JL, Sadeghi MM. Novel Molecular Imaging Approaches to Abdominal Aortic Aneurysm Risk Stratification. Circ Cardiovasc Imaging. 2016 Jan;9(1):e003023. doi: 10.1161/CIRCIMAGING.115.003023.

  PMID: 26763279 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Robert Gropler, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kitty Harrison, RN, BSN

CONTACT

314-747-0183; kittydharrison@wustl.edu

Robert Gropler, MD

CONTACT

314-747-0183; rgropler@wustl.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: March 16, 2026
• Study Start: November 3, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)