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Trial record 9 of 292 for:    Sodium Fluoride OR Duraphat

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

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ClinicalTrials.gov Identifier: NCT03530176
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Paolo Raggi, MD, University of Alberta

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Complications of Diabetes Mellitus Radiation: 18Fluoride-Sodium Fluoride radio-isotope Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-Sodium Fluoride (18F-NaF) PET-CT Imaging to Identify Vulnerable Plaques in Patients With Diabetes
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : October 15, 2017
Actual Study Completion Date : October 15, 2017

Resource links provided by the National Library of Medicine


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 Name: 18F-NaF




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530176


Locations
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Canada, Alberta
University Hospital of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Paolo Raggi, MD Professor of Medicine, University of Alberta

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paolo Raggi, MD, Section Chief of Cardiology, Mazankowski Alberta Heart Institute, University of Alberta
ClinicalTrials.gov Identifier: NCT03530176     History of Changes
Other Study ID Numbers: Pro00049579
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Atherosclerosis
Diabetes Mellitus
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents