Abdominal Aortic AneurysmNCT04811222
DOTATATE PETMRI AAA Study
A study testing Ga-DOTATATE PETMRI scan in people with Abdominal Aortic Aneurysm, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Abdominal Aortic Aneurysm (AAA) screening and an aging population have increased the prevalence of AAA diagnoses. Small AAAs (<5.5cm) are monitored with ultrasound. Large AAAs may rupture and this is usually fatal. Surgery is considered at a crude size threshold of 5.5cm when the annual rupture risk reaches 5%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Ga-DOTATATE PETMRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of asymptomatic abdominal aortic aneurysm AAA >3cm in maximum diameter;
- Minimum 2 years prior ultrasound or CT imaging of their AAA;
- No prior treatment for AAA;
- Age >50 years;
- No contraindications to PET/MRI, such as claustrophobia;
Who cannot join
- Pregnant females. All women of child-bearing potential must receive a negative urine pregnancy test prior to administration of 68Ga-DOTATATE;
- Allergy and/or hypersensitivity to MRI contrast agents (gadolinium) or components of 68Ga-DOTATATE drug product (as listed in IB);
- Presence of pacemaker or implanted cardioverter defibrillator (ICD);
- History of alcohol or substance abuse.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2N2
Iris Zhong, 416-946-4501 ext. 4816, iris.zhong@uhn.ca
About this study
Official title: Gallium-DOTATATE PET-MR Imaging to Detect Macrophages in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm (AAA) screening and an aging population have increased the prevalence of AAA diagnoses. Small AAAs (<5.5cm) are monitored with ultrasound. Large AAAs may rupture and this is usually fatal. Surgery is considered at a crude size threshold of 5.5cm when the annual rupture risk reaches 5%. AAA size is the only predictor of growth and rupture available but growth is non-linear and some small AAAs rupture. Thus, only 1 in 20 patients treated at 5.5cm will have benefited from rupture prevention in the year following surgery, and others may miss out on life-saving surgery. This study will develop an imaging tool PETMRI with radiotracer Ga- DOTATATE with high clinical utility, to improve prediction of aneurysm growth and risk.
Read the detailed description
The prevalence of abdominal aortic aneurysm (AAA) in those over 65 years is 4-8% and rising. Currently, AAA size is the only metric to determine risk of growth/rupture; we are unable to image the underlying disease process. Using size alone is problematic. For small AAAs there is no consensus between surgical societies on appropriate surveillance intervals. AAA growth is non-linear and thus some small AAAs may rupture between screening intervals.
Macrophage mediated inflammation leads to weakening of the aortic wall. Our own laboratory work indicates macrophages correlate with AAA severity in mice. In humans, activated macrophages express SomatoSTatin Receptor 2 (SSTR2). For the first time ever, using a radiotracer probe specific for SSTR 2 (gallium-dotatate), we will detect activated macrophages in AAAs using Positron Emission Tomography- Magnetic Resonance Imaging (PET-MRI). Patients attending the University Health Network (UHN) Vascular clinic undergoing ultrasound surveillance of small AAAs of differing sizes will be imaged with Ga-Dotatate PET-MRI. We will correlate aneurysm size and anatomical information with in-vivo imaging of aortic macrophages detected with Ga-Dotatate, to determine the risk of aneurysm growth.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Ga-DOTATATE PETMRI scan
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-DOTATATE PETMRI scanDiagnostic test
Patients with AAA with minimum 2 years surveillance will have one time Ga-DOTATATE PETMRI scan
| Study group | Role | What they receive |
|---|---|---|
| Ga-DOTATATE PET/MRI scan | Experimental | Patients with abdominal aortic aneurysm will undergo Ga-DOTATATE PET/MRI scan Receives: Diagnostic Test: Ga-DOTATATE PETMRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
68-Ga DOTATATE uptake
Measuring AAA patient's 68-Ga DOTATATE uptake using PET/MRI as a marker of macrophage accumulation
Measured: within 6 months after obtaining consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start15 Feb 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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 Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ga-DOTATATE PETMRI scan
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Veit-Haibach, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811222
- Sponsor's protocol ID
- 20-5802
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gallium-DOTATATE PET-MR Imaging to Detect Macrophages in Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT04811222
- Acronym / sponsor ID
- 20-5802
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Mar 2021 (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.
Abdominal Aortic Aneurysm (AAA) screening and an aging population have increased the prevalence of AAA diagnoses. Small AAAs (<5.5cm) are monitored with ultrasound. Large AAAs may rupture and this is usually fatal. Surgery is considered at a crude size threshold of 5.5cm when the annual rupture risk reaches 5%. AAA size is the only predictor of growth and rupture available but growth is non-linear and some small AAAs rupture. Thus, only 1 in 20 patients treated at 5.5cm will have benefited from rupture prevention in the year following surgery, and others may miss out on life-saving surgery. This study will develop an imaging tool PETMRI with radiotracer Ga- DOTATATE with high clinical utility, to improve prediction of aneurysm growth and risk.
Detailed description
The prevalence of abdominal aortic aneurysm (AAA) in those over 65 years is 4-8% and rising. Currently, AAA size is the only metric to determine risk of growth/rupture; we are unable to image the underlying disease process. Using size alone is problematic. For small AAAs there is no consensus between surgical societies on appropriate surveillance intervals. AAA growth is non-linear and thus some small AAAs may rupture between screening intervals.
Macrophage mediated inflammation leads to weakening of the aortic wall. Our own laboratory work indicates macrophages correlate with AAA severity in mice. In humans, activated macrophages express SomatoSTatin Receptor 2 (SSTR2). For the first time ever, using a radiotracer probe specific for SSTR 2 (gallium-dotatate), we will detect activated macrophages in AAAs using Positron Emission Tomography- Magnetic Resonance Imaging (PET-MRI). Patients attending the University Health Network (UHN) Vascular clinic undergoing ultrasound surveillance of small AAAs of differing sizes will be imaged with Ga-Dotatate PET-MRI. We will correlate aneurysm size and anatomical information with in-vivo imaging of aortic macrophages detected with Ga-Dotatate, to determine the risk of aneurysm growth.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ga-DOTATATE PETMRI scan
| Arm | Type | Receives |
|---|---|---|
| Ga-DOTATATE PET/MRI scan | Experimental | Diagnostic Test: Ga-DOTATATE PETMRI scanPatients with abdominal aortic aneurysm will undergo Ga-DOTATATE PET/MRI scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of asymptomatic abdominal aortic aneurysm AAA >3cm in maximum diameter;
- Minimum 2 years prior ultrasound or CT imaging of their AAA;
- No prior treatment for AAA;
- Age >50 years;
- No contraindications to PET/MRI, such as claustrophobia;
Key exclusion criteria (4 listed)
- Pregnant females. All women of child-bearing potential must receive a negative urine pregnancy test prior to administration of 68Ga-DOTATATE;
- Allergy and/or hypersensitivity to MRI contrast agents (gadolinium) or components of 68Ga-DOTATATE drug product (as listed in IB);
- Presence of pacemaker or implanted cardioverter defibrillator (ICD);
- History of alcohol or substance abuse.
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 |
|---|---|---|
| Ga-DOTATATE PETMRI scanPatients with AAA with minimum 2 years surveillance will have one time Ga-DOTATATE PETMRI scan | Diagnostic test | Ga-DOTATATE PET/MRI scan |
Primary outcome
68-Ga DOTATATE uptake
Time frame: within 6 months after obtaining consent
Measuring AAA patient's 68-Ga DOTATATE uptake using PET/MRI as a marker of macrophage accumulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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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. This study is not recruiting at the moment.
Patrick Veit-Haibach principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ga-DOTATATE PETMRI scan in people with Abdominal Aortic Aneurysm, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iris Zhong (416-946-4501 ext. 4816, iris.zhong@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
68-Ga DOTATATE uptake (time frame: within 6 months after obtaining consent). 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 23 Mar 2021.