Studying the utility of [68Ga] FAPI PET CT in Cardiac Sarcoidosis – a pilot study

Not Applicable

• Conditions: Cardiac Sarcoidosis; Cardiovascular - Other cardiovascular diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12622000637741
• Lead Sponsor: Mercy Radiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-02
• Last Update Posted: 24 April 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

•Patient age >= 18 years.
• All patients deemed by the Auckland sarcoid multidisciplinary team to have newly diagnosed, confirmed cardiac sarcoid based on histopathological/clinical/imaging data and who have had a CMR and [18F]FDG PET/CT as part of their diagnostic work up.
•Able to give informed consent
•Willing to use effective contraceptive methods for the duration of the study 90 days after receiving the IMP

Exclusion Criteria

•All pts in which the diagnosis could not be confirmed.
•Pts with confirmed disease who have not had [18F]FDG PET CT or CMR
•Patients who have started therapy for cardiac sarcoidosis.
•Patients unable, or unwilling to consent
•females of childbearing potential must have a negative pregnancy test on the day of treatment study initiation). Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
•Breastfeeding mothers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retention rate (number of patients completing the study /number of patients enrolled) and reasons for discontinuing the study before completion.<br><br>This information will determine feasibility for a larger multicentre trial<br>This data will be collected via audit of study records<br>[at completion of the trial]

Secondary Outcome Measures

Name	Time	Method
umber of patients with cardiac uptake at [68Ga]Ga-FAPI PET/CT deemed diagnostic by study criteria<br><br>This information will determine if [68Ga]Ga-FAPI is a more effective agent in diagnosing cardiac sarcoidosis.<br>[24 hours post PET CT]