d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03549598
• Date of registration: 25/05/2018
• Prospective Registration: Yes
• Primary sponsor: Mayo Clinic
• Public title: d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
• Scientific title: d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
• Date of first enrolment: July 20, 2018
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03549598
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: John P Bois
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years of age or older

- Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)

Exclusion Criteria:

- Pregnant

- Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cardiac Sarcoidosis

Intervention(s)

Drug: 13NH3 PET/CT scan

Drug: 18FDG PET/CT scan

Drug: 68Ga-DOTATATE PET/CT

Primary Outcome(s)

13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS) [Time Frame: 2 days]

18FDG Uptake With Cardia Sarcoidosis (CS) [Time Frame: 2 days]

68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS) [Time Frame: 3 days]

Secondary Outcome(s)

Subject Satisfaction [Time Frame: 2 days]

Physician Confidence in Study Interpretation [Time Frame: 2 days]

Secondary ID(s)

18-000393

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03549598