18F-FDG PET Imaging in Cardiac Sarcoidosis

NCT01764191 | Unknown

• 1 other identifier: BCCA-Cardiac PET
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study has been designed to provide patients suspected of having cardiac sarcoidosis (CS) with a potentially diagnostic 18F FDG PET/CT. CS is difficult to diagnose with currently available methods, therefore this project will allow access to 18F FDG PET/CT scanning, which may more accurately diagnose the presence of CS. This study will also provide additional data to further examine the effectiveness and safety profile of 18F FDG for this condition. Accurate and early detection is important to allow for better management of CS and improve patient care. The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety and effectiveness of 18F-FDG PET/CT in this patient population

Conditions

Cardiac Sarcoidosis

Interventions

18F-Fluorodeoxyglucose (18F-FDG) PET/CT OTHER

All subjects suspected of cardiac sarcoidosis will receive an intravenous dose of 18F-FDG (determined by weight, but not to exceed 521 MBq). Following an uptake phase of about 60 minutes, each subject will receive a PET/CT scan to evaluate the presence of cardiac sarcoidosis.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 years or older.
• Eastern Cooperative Oncology Group(ECOG) performance status 0 - 3.
• Able to provide written informed consent.
• Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 45 minutes and tolerating intravenous cannulation for injection.
• Clinical suspicion of cardiac sarcoidosis, including a combination of:
• Patients with systemic sarcoidosis and symptoms suggestive of heart failure (eg. fatigue, dyspnea, edema etc.)
• Idiopathic heart failure, particularly of preserved systolic function variety
• Presentation with arrhythmia (eg. heart block, ventricular tachycardia, etc.)
• Progressive heart failure symptoms not responding to conventional therapy
• Other clinical presentations where in the experience of treating cardiologist cardiac sarcoid needs to be ruled out (ie. Heart transplant or ventricular assist device candidacy)
• Routine tests for CS are inconclusive, such as:
• ECG
• Holter
• echocardiogram
• Ga scintigraphy is inconclusive

You may not qualify if:

• Patients blood glucose \> 11.1 mmol/L (200 mg/dL) measured by glucometer immediately prior to scan.
• Patients with confirmed diabetes.
• Patients unable to comply with the dietary modifications or prolonged fasting as per trial protocol.
• Pregnancy.
• Patients who are medically unstable eg. acute cardiac or respiratory distress, or hypotensive.
• Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT machine (diameter 70 cm).

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 9, 2013
• Last Updated: February 4, 2022

Record last verified: 2022-02

Locations

CA (1)