Brief Title
DOTATATE PETMRI AAA Study
Official Title
Gallium-DOTATATE PET-MR Imaging to Detect Macrophages in Abdominal Aortic Aneurysms
Brief 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%. 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 Type
Interventional
Primary Outcome
68-Ga DOTATATE uptake
Condition
Abdominal Aortic Aneurysm
Intervention
Ga-DOTATATE PETMRI scan
Study Arms / Comparison Groups
Ga-DOTATATE PET/MRI scan
Description: Patients with abdominal aortic aneurysm will undergo Ga-DOTATATE PET/MRI scan
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
55
Start Date
February 15, 2021
Completion Date
December 31, 2023
Primary Completion Date
December 31, 2023
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of asymptomatic abdominal aortic aneurysm AAA >3cm in maximum diameter;
2. Minimum 2 years prior ultrasound or CT imaging of their AAA;
3. No prior treatment for AAA;
4. Age >50 years;
5. No contraindications to PET/MRI, such as claustrophobia;
Exclusion Criteria:
1. Pregnant females. All women of child-bearing potential must receive a negative urine
pregnancy test prior to administration of 68Ga-DOTATATE;
2. Allergy and/or hypersensitivity to MRI contrast agents (gadolinium) or components of
68Ga-DOTATATE drug product (as listed in IB);
3. Presence of pacemaker or implanted cardioverter defibrillator (ICD);
4. History of alcohol or substance abuse.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Patrick Veit-Haibach, 416-946-4501, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT04811222
Organization ID
20-5802
Responsible Party
Sponsor
Study Sponsor
University Health Network, Toronto
Study Sponsor
Patrick Veit-Haibach, Principal Investigator, University Health Network, Toronto
Verification Date
March 2021