DOTATATE PETMRI AAA Study

NCT04811222 | Unknown

• 1 other identifier: 20-5802
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• 68-Ga DOTATATE uptake

  Measuring AAA patient's 68-Ga DOTATATE uptake using PET/MRI as a marker of macrophage accumulation

  within 6 months after obtaining consent

Study Arms (1)

Ga-DOTATATE PET/MRI scan

EXPERIMENTAL

Patients with abdominal aortic aneurysm will undergo Ga-DOTATATE PET/MRI scan

Diagnostic Test: Ga-DOTATATE PETMRI scan

Interventions

Ga-DOTATATE PETMRI scan DIAGNOSTIC_TEST

Patients with AAA with minimum 2 years surveillance will have one time Ga-DOTATATE PETMRI scan

Ga-DOTATATE PET/MRI scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Patrick Veit-Haibach

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Zhong

CONTACT

416-946-4501; iris.zhong@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Ga-DOTATATE PETMRI scan

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 23, 2021
• Study Start: February 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

CA (1)