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First-in-Human scan spots hidden danger in aortic aneurysms

NCT ID NCT07473102

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a new radioactive tracer called [64Cu]-RYM2 to see if it can safely and accurately detect enzyme activity in abdominal aortic aneurysms (AAA). Researchers will scan 28 people—some healthy volunteers and some AAA patients scheduled for surgery—to measure how the tracer spreads in the body and whether it highlights the aneurysm. The goal is to improve understanding of AAA and potentially guide future treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.