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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• • Measure uptake of 64Cu-DOTA-ECL1 [Time frame: 3 months]

Secondary outcome measures (1)

• Comparing 64Cu-DOTA-ECL1i uptake [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

United States · 1 center

• Penn Medicine; Perelman School of Medicine — Philadelphia

Identifiers

NCT: NCT07548099 · UPENN IRB# 858617 · UPENN IRB# 25-0899 (858617)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗