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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Drug: 64Cu-DOTA-ECL1i

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Erin Schubert; Phone Number: 215-573-6569; Email: Erin.schubert@pennmedicine.upenn.edu
• Study Contact Backup: Name: Mary Hansbury; Phone Number: 215-746-8192; Email: mary.hansbury@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Medicine; Perelman School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 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:

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 child-bearing potential 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 GFR 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 life expectancy as deemed by the treating physician at the time of initial enrollment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants diagnosed with Abdominal Aortic Aneurysm (AAA); Established diagnosis of abdominal aortic aneurysm based on standard clinical criteria.	Drug: 64Cu-DOTA-ECL1i; 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; Age-matched participants without a diagnosis of AAA as a control group.	Drug: 64Cu-DOTA-ECL1i; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing 64Cu-DOTA-ECL1i uptake	• Compare 64Cu-DOTA-ECL1i uptake between AAA and control individuals.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate uptake of 64Cu-DOTA-ECL1i	Correlate uptake of 64Cu-DOTA-ECL1i in the aortic wall with morphologic features on CTA.	3 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Scott M Damrauer, MD, Penn Medicine Division of Vascular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: aortic aneurysm; aortic inflammation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: UPENN IRB# 858617; UPENN IRB# 25-0899 (858617) (Other Identifier: UPENN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is an internal study and there are no plans to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No