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NCT Number: NCT07548099

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn Medicine; Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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 child-bearing potential before the injection of radiotracer.
  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • Patients with chronic renal disease whose GFR is less than 40 mL/min/1.73m² at the time of enrollment.
  • Documented allergy to iodinated contrast
  • 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
  • Less than 6 months life expectancy as deemed by the treating physician at the time of initial enrollment.

Treatment and study plan

64Cu-DOTA-ECL1i

Drug

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.

Primary outcomes

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

    Time frame: 3 months

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

Secondary outcomes

  1. Comparing 64Cu-DOTA-ECL1i uptake

    Time frame: 3 months

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

Other outcomes

  1. Correlate uptake of 64Cu-DOTA-ECL1i

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Schubert

CONTACT

[email protected]

215-573-6569

Mary Hansbury

CONTACT

[email protected]

215-746-8192

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 23, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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