18F-Sodium Fluoride (18F-NaF) PET-CT Imaging to Identify Vulnerable Plaques in Patients With Diabetes (D-NaF)

May 17, 2018 updated by: Paolo Raggi, MD, University of Alberta
Coronary artery calcification is a sign of heart disease. A nuclear medicine PET-CT test using sodium fluoride (18F-NaF) radioisotope has been shown to help identify growing calcification plaques early on in the disease process. It is known that diabetic patients are at a high risk of developing premature coronary disease; the investigators intend to use this new technology to identify those patients at higher risk of developing coronary artery disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic patients are at very high risk of suffering premature coronary artery disease events compared to the general population. Whether pancreas transplant completely reverses the biochemical imbalances of diabetes mellitus and the high cardiovascular risk of these patients is unclear. Investigators in the field of imaging have been looking for ways to identify patients at greater risk of suffering events by searching for plaques in the cardiovascular system more likely to fracture and cause acute intravascular thrombosis (vulnerable plaques) with subsequent precipitation of acute events. Recent advances in PET-CT provide an opportunity to pursue such search with limited risk to the patient and high probability of success. CT scanning is used to identify vascular calcification -a marker of atherosclerosis- and PET imaging with 18F-NaF helps determine whether the calcification is actively accumulating calcium and phosphorus making it an actively growing plaque. PET imaging with 18F-NaF has been used in the setting of acute coronary syndromes to identify the most active and unstable plaques and in patients with severe aortic valve stenosis to follow the natural history of this disease. The investigators propose to perform PET-CT imaging with 18F-NaF in a pilot study of 100 patients chosen among the subjects followed in the outpatient diabetes clinics at the University of Alberta. The aim is to investigate the presence and extent of unstable plaques in ambulatory patients affected by diabetes, and to identify a set of clinical variables most likely to be associated with a large burden of disease. Since there are no published studies in this particular field it is impossible to make precise sample size calculations and these analyses must therefore be considered exploratory.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University Hospital of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

> 18 years of age. Has an established diagnosis of diabetes mellitus type 1 or 2. Stable clinical course with a stable medical regimen for 6 months prior to enrollment.

-

Exclusion Criteria:

Unable to give consent. Weight >250 kg. Unable to lie flat for 20-30 minutes to complete the PET-CT session. Pregnancy, breast feeding, known history of primary hyperparathyroidism or metabolic bone disease, recent malignancy (<3 years) or previous thoracic irradiation.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: single arm
18F-NaF (sodium Flouride ) is a radio-pharmaceutical used to image skeletal pathology, including primary and secondary neoplasms. Despite US Federal Drug Administration (FDA) approval and 18F-NaF being listed in the US Pharmacopeia, 18F-NaF is not currently approved by Health Canada for use as a cardiac imaging tracer. Therefore, a concurrent Health Canada Clinical Trial Application is being submitted to ensure its availability. Intervention on single arm: A dose of 18F-NaF (200 - 400 MBq) will be injected intravenously at rest. After a 60 minute, an ECG-gated PET acquisition will be performed centered over the heart for 20 minutes. A CT coronary calcium score examination will also be performed on a dedicated CT scanner and the Agatston and volume scores calculated according to standards.
Radiation: 18Fluoride-Sodium Fluoride radio-isotope
The investigators will be using 18F-NaF to image premature atherosclerosis in the coronary arteries of diabetic patients.
Other Names:
  • 18F-NaF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
18F-Sodium Fluoride (18F-NaF) PET-CT Imaging to Identify Vulnerable Plaques in Patients With Diabetes
Time Frame: 4-6 weeks
Prevalence of patients with type-2 diabetes and unstable, high-risk coronary artery plaques
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Paolo Raggi, MD, Professor of Medicine, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

October 15, 2017

Study Completion (ACTUAL)

October 15, 2017

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

May 17, 2018

First Posted (ACTUAL)

May 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00049579

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atherosclerosis

Clinical Trials on 18Fluoride-Sodium Fluoride radio-isotope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe