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Abdominal Aortic AneurysmEarly Phase 1PET AAANCT07473102

PET Imaging of MMP Activation in AAA: Clinical Component

A Early Phase 1 study testing Cu-64-RYM2 and PET imaging using Cu-64 in people with Abdominal Aortic Aneurysm, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Abdominal Aortic Aneurysm
What is being tested?
Cu-64-RYM2 and PET imaging using Cu-64
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
3 Nov 2025to 31 Mar 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kitty Harrison, RN, BSN contact

314-747-0183

kittydharrison@wustl.edu

Robert Gropler, MD contact

314-747-0183

rgropler@wustl.edu

United States1 site, 1 recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Kitty Harrison, RN, BSN, 314-747-0183, kittydharrison@wustl.edu

    Robert Gropler, MD, 314-747-0183

    Recruiting

Other trials in United States

About this study

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).

Read the 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).

Being tested
Cu-64-RYM2, PET imaging using Cu-64
Keywords
Imaging for Aneurysm Abdominal, Imaging for Abdominal Aneurysms
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cu-64-RYM2Drug

    PET/CT scan

  • PET imaging using Cu-64Drug

    PET/CT at different timepoints

Study groups in NCT07473102
Study groupRoleWhat they receive
dosimetry and AAA patientsOtherPatients who have abdominal aortic aneurysm and healthy volunteers
Receives: Drug: Cu-64-RYM2; Drug: PET imaging using Cu-64

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (1)

  1. Cu-64RYM-2 signal is higher

    MMP activity will be higher in AAA patients than in healthy volunteers

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2026
  2. Study start3 Nov 2025
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07473102
Sponsor's protocol ID
202505027
Acronym
PET AAA
Status last verified
Mar 2026
First submitted
3 Dec 2025
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Only de-identified images will be shared

Publications

  • 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.

    PubMed 18936327

  • 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.

    PubMed 26352243

  • 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.

    PubMed 27903546

  • 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.

    PubMed 24381115

  • 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.

    PubMed 25427112

  • 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.

    PubMed 25060754

  • 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.

    PubMed 26763279

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Cu-64-RYM2 and PET imaging using Cu-64 in people with Abdominal Aortic Aneurysm, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kitty Harrison, RN, BSN (314-747-0183, kittydharrison@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07473102, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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