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

NCT07548099 | Not Yet Recruiting FDA Drug

• 2 other identifiers: UPENN IRB# 858617UPENN IRB# 25-0899 (858617)
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Aortic Aneurysm

Keywords

aortic aneurysm; aortic inflammation

Outcome Measures

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

  3 months

Secondary Outcomes (1)

• Comparing 64Cu-DOTA-ECL1i uptake

  3 months

Other Outcomes (1)

• Correlate uptake of 64Cu-DOTA-ECL1i

  3 months

Study Arms (2)

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

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.

Control Group; Participants diagnosed with Abdominal Aortic Aneurysm (AAA)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine; Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken at various time points to measure the concentration of the imaging drug in the blood during the scan. Participants will provide a total of approximately 20 mL of blood on the day of each PET/CT scan i.e., a total blood volume of approximately 40 mL (less than 3 tablespoons)

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Scott M Damrauer, MD

  Penn Medicine Division of Vascular Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Schubert

CONTACT

215-573-6569; erin.schubert@pennmedicine.upenn.edu

Mary Hansbury

CONTACT

215-746-8192; mary.hansbury@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 23, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)