DOTATATE PETMRI AAA Study
Primary Purpose
Abdominal Aortic Aneurysm
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ga-DOTATATE PETMRI scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Aortic Aneurysm
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Sites / Locations
- University Health NetworkRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ga-DOTATATE PET/MRI scan
Arm Description
Patients with abdominal aortic aneurysm will undergo Ga-DOTATATE PET/MRI scan
Outcomes
Primary Outcome Measures
68-Ga DOTATATE uptake
Measuring AAA patient's 68-Ga DOTATATE uptake using PET/MRI as a marker of macrophage accumulation
Secondary Outcome Measures
Full Information
NCT ID
NCT04811222
First Posted
March 10, 2021
Last Updated
March 19, 2021
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04811222
Brief Title
DOTATATE PETMRI AAA Study
Official Title
Gallium-DOTATATE PET-MR Imaging to Detect Macrophages in Abdominal Aortic Aneurysms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Ga-DOTATATE PETMRI scan
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ga-DOTATATE PET/MRI scan
Arm Type
Experimental
Arm Description
Patients with abdominal aortic aneurysm will undergo Ga-DOTATATE PET/MRI scan
Intervention Type
Diagnostic Test
Intervention Name(s)
Ga-DOTATATE PETMRI scan
Intervention Description
Patients with AAA with minimum 2 years surveillance will have one time Ga-DOTATATE PETMRI scan
Primary Outcome Measure Information:
Title
68-Ga DOTATATE uptake
Description
Measuring AAA patient's 68-Ga DOTATATE uptake using PET/MRI as a marker of macrophage accumulation
Time Frame
within 6 months after obtaining consent
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Zhong
Phone
416-946-4501
Ext
4816
Email
iris.zhong@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Veit-Haibach
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Zhong
Phone
416-946-4501
Ext
4816
Email
iris.zhong@uhn.ca
12. IPD Sharing Statement
Learn more about this trial
DOTATATE PETMRI AAA Study
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