Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811222
Status:
UNKNOWN
Last Update Posted:
2021-03-23
First Post:
2021-03-10
Brief Title:
DOTATATE PETMRI AAA Study
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Gallium-DOTATATE PET-MR Imaging to Detect Macrophages in Abdominal Aortic Aneurysms
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Abdominal Aortic Aneurysm AAA screening and an aging population have increased the prevalence of AAA diagnoses Small AAAs 55cm are monitored with ultrasound Large AAAs may rupture and this is usually fatal Surgery is considered at a crude size threshold of 55cm 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 55cm 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 growthrupture 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None