ClinicalTrials.gg
RecruitingNCT07548099Updated May 22, 2026

Molecular Imaging of the Underlying Mechanism of Vessel Wall Inflammation Using Positron Emission Tomography (PET/CT)

An observational study in Abdominal Aortic Aneurysm, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University of Pennsylvania · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

This research study is being conducted to test how an imaging drug called 64Cu-DOTA-ECL1i can be used to image an abdominal aortic aneurysm. 64Cu-DOTA-ECL1i is a drug used with an imaging test called a PET/CT (Positron Emission Tomography/Computed Tomography).

The aim is to collect data using a new imaging drug called 64Cu-DOTA-ECL1i that may be able to create images of inflammation in the aorta, which is thought to be important in how aneurysms grow and develop and to understand how consistent these scans are across time and what might affect the inflammation.

Read the detailed description

Abdominal aortic aneurysm (AAA) is a life-threatening condition in which progressive dilatation of the infrarenal aorta leads to rupture. With \~2.3 million prevalent cases, AAA afflicts \~4% of the U.S. population ≥ 65 years of age and is responsible for \~41,000 deaths annually 4,5. No pharmacologic therapies exist that prevent AAA development, growth, rupture, or aneurysm-related deaths. No diagnostic approaches exist to predict which AAAs will grow and eventually rupture.

The study will use the radiotracer 64Cu-DOTA-ECL1i to assess the aortic wall in individuals with AAA and repeat these exams approximately 6-8 weeks after baseline to evaluate longitudinal biological variation in uptake and the impact of any clinical changes or treatment effects on tracer uptake. These data will provide insight into molecular imaging of AAA.

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Conditions studied

  • Abdominal Aortic Aneurysm

Keywords

  • aortic aneurysm
  • aortic inflammation
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In context

Aortic Aneurysm, Abdominal

467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.

This study's planned enrollment of 30 is below the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

We plan to enroll up to 15 fully evaluable adult participants in this pilot study who have an established diagnosis of AAA and up to 5 fully evaluable adult participants who do not have a diagnosis of AAA.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants will be at least 18 years of age
  2. Have an established diagnosis of abdominal aortic aneurysm based on standard clinical criteria or are an age matched control with absence of known AAA.
  3. Participants must be informed of the nature of this study and be willing to provide written and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion criteria

Exclusion Criteria:

  1. Females who are pregnant or breast feeding at the time of the PET/CT scan will not be eligible for this study; a urine pregnancy test will be performed in women of before the injection of radiotracer.
  2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  3. Patients with chronic renal disease whose is less than 40 mL/min/1.73m² at the time of enrollment.
  4. Documented allergy to iodinated contrast
  5. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
  6. Less than 6 months as deemed by the treating physician at the time of initial enrollment.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Participants diagnosed with Abdominal Aortic Aneurysm (AAA)

    Established diagnosis of abdominal aortic aneurysm based on standard clinical criteria.

    Drug: 64Cu-DOTA-ECL1i

  • Control Group

    Age-matched participants without a diagnosis of AAA as a control group.

    Drug: 64Cu-DOTA-ECL1i

Interventions

  • The radiotracer 64Cu-DOTA-ECL1i will be used to assess the aortic wall in individuals with AAA and age-matched participants without a diagnosis of AAA as a control group.

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What researchers measure

Primary outcomes

  1. • Measure uptake of 64Cu-DOTA-ECL1

    • Measure uptake of 64Cu-DOTA-ECL1i in patients with abdominal aortic aneurysm at two time points to evaluate intra-individual variability of radiotracer uptake

    Time frame: 3 months

Secondary outcomes

  1. Comparing 64Cu-DOTA-ECL1i uptake

    • Compare 64Cu-DOTA-ECL1i uptake between AAA and control individuals.

    Time frame: 3 months

Other outcomes

  1. Correlate uptake of 64Cu-DOTA-ECL1i

    Correlate uptake of 64Cu-DOTA-ECL1i in the aortic wall with morphologic features on CTA.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Penn Medicine; Perelman School of Medicine
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — This is an internal study and there are no plans to share data.

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Apr 2028, 24 months after the start.

Of 67 non-industry observational studies under Aortic Aneurysm, Abdominal, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's planned 24 months is below that.

Counting every sponsor, half of 91 studies reached it within 48 months; a quarter within 24 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2026
First posted
Apr 23, 2026
StartActual
Apr 30, 2026
Primary completionEst.
Apr 30, 2028
CompletionEst.
Apr 30, 2029
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07548099
Responsible party
Sponsor
First posted
Apr 23, 2026
Start date
Apr 30, 2026
Primary completion
Apr 30, 2028 (estimated)
Completion
Apr 30, 2029 (estimated)
Last update
May 22, 2026

Study contacts

Erin Schubert
Contact
erin.schubert@pennmedicine.upenn.edu
215-573-6569
Mary Hansbury
Contact
mary.hansbury@pennmedicine.upenn.edu
215-746-8192
Scott M Damrauer, MD
principal investigator · Penn Medicine Division of Vascular Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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