PET Imaging in Patients With Suspected Cardiac Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT03746847
• Date of registration: 29/10/2018
• Prospective Registration: Yes
• Primary sponsor: University of Pennsylvania
• Public title: PET Imaging in Patients With Suspected Cardiac Sarcoidosis
• Scientific title: Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
• Date of first enrolment: December 1, 2018
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03746847
• Study type: Observational

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Participants will be = 18 years of age

2. History of biopsy-proven sarcoidosis OR suspected sarcoidosis based on standard
clinical imaging (e.g. FDG PET/CT, MRI) without biopsy confirmation

3. Clinical suspicion of cardiac involvement defined as the presence of any of the
following:

1. High degree A-V nodal block

2. Complete bundle branch block

3. Reduced left or right ventricular systolic fusion

4. Any cardiac arrhythmia

5. Chest pain, dyspnea or syncope without clear etiology

4. FDG PET/CT scan demonstrating abnormal myocardial FDG uptake

5. Participants must be informed of the investigational nature of this study and be
willing to provide written informed consent and participate in this study in
accordance with institutional and federal guidelines prior to study-specific
procedures

Exclusion Criteria:

1. Females who are pregnant or breast feeding at the time of screening will not be
eligible for this study; a urine pregnancy test will be performed in women of
child-bearing potential at screening.

2. History of neuroendocrine tumors

3. Currently taking the medication Octreotide

4. Currently on total parenteral nutrition (TPN)

5. Inability to tolerate imaging procedures in the opinion of an investigator or treating
physician

6. Any current medical condition, illness, or disorder as assessed by medical record
review and/or self-reported that is considered by a physician investigator to be a
condition that could compromise participant safety or successful participation in the
study



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

Health Condition(s) or Problem(s) studied

Cardiac Sarcoidosis

Intervention(s)

Drug: Gallium-68 DOTATATE

Primary Outcome(s)

Dotatate SUVmax activity in the heart [Time Frame: 3 years]

Secondary Outcome(s)

Change in Dotatate SUVmax activity in the heart on follow-up PET/CT scan compared to baseline [Time Frame: 3 years]

Secondary ID(s)

829715

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Advanced Accelerator Applications