Abdominal Aortic AneurysmNCT07548099
Molecular Imaging of the Underlying Mechanism of Vessel Wall Inflammation Using Positron Emission Tomography (PET/CT)
An observational study of Abdominal Aortic Aneurysm, run by University of Pennsylvania at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- 64Cu-DOTA-ECL1i
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn Medicine; Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- 64Cu-DOTA-ECL1i
- Keywords
- aortic aneurysm, aortic inflammation
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-DOTA-ECL1iDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants diagnosed with Abdominal Aortic Aneurysm (AAA) | Established diagnosis of abdominal aortic aneurysm based on standard clinical criteria. Receives: Drug: 64Cu-DOTA-ECL1i | |
| Control Group | Age-matched participants without a diagnosis of AAA as a control group. Receives: Drug: 64Cu-DOTA-ECL1i |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: 3 months
Secondary outcomes (1)
Comparing 64Cu-DOTA-ECL1i uptake
- Compare 64Cu-DOTA-ECL1i uptake between AAA and control individuals.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start30 Apr 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott M Damrauer, MD, Principal investigator, Penn Medicine Division of Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548099
- Sponsor's protocol ID
- UPENN IRB# 858617
- Other IDs
- UPENN IRB# 25-0899 (858617)
- Status last verified
- May 2026
- First submitted
- 13 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is an internal study and there are no plans to share data.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging of the Underlying Mechanism of Vessel Wall Inflammation Using Positron Emission Tomography (PET/CT)
- ClinicalTrials.gov ID
- NCT07548099
- Acronym / sponsor ID
- UPENN IRB# 858617
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- aortic aneurysm, aortic inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants diagnosed with Abdominal Aortic Aneurysm (AAA) | – | Drug: 64Cu-DOTA-ECL1iEstablished diagnosis of abdominal aortic aneurysm based on standard clinical criteria. |
| Control Group | – | Drug: 64Cu-DOTA-ECL1iAge-matched participants without a diagnosis of AAA as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 64Cu-DOTA-ECL1iThe 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. | Drug | Control Group, Participants diagnosed with Abdominal Aortic Aneurysm (AAA) |
Primary outcome
• 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
1 secondary outcome
Comparing 64Cu-DOTA-ECL1i uptake
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. This is an internal study and there are no plans to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott M Damrauer, MD principal investigator
Penn Medicine Division of Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Schubert (215-573-6569, erin.schubert@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Measure uptake of 64Cu-DOTA-ECL1 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.