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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Participants diagnosed with Abdominal Aortic Aneurysm (AAA)1 intervention
Group B: Control Group1 intervention

Trial outcomes

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

Sponsors and contacts

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