Recruiting

DOTATATE PETMRI

Sponsor:

University Health Network, Toronto

Code:

NCT04811222

Conditions

Abdominal Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ga-DOTATATE PETMRI scan

Study Details

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

Study ID

NCT04811222

Start date

Feb 15, 2021

Status verified date

Mar, 2021

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Ga-DOTATATE PET/MRI scan

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

Interventions

Ga-DOTATATE PETMRI scan

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

Primary outcome measure

  • 68-Ga DOTATATE uptake [ Time Frame: within 6 months after obtaining consent ]

Central Contacts and Locations

Central contacts

Iris Zhong

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

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Iris Zhong

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 23, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2021-03-23.