PET Imaging in Patients With Suspected Cardiac Sarcoidosis

Completed

• Conditions: Cardiac Sarcoidosis
• Interventions: Drug: Gallium-68 DOTATATE

• Registration Number: NCT03746847
• Lead Sponsor: University of Pennsylvania

Brief Summary

Gallium-68 DOTATATE is a radioactive tracer, a type of imaging drug that is labeled with a radioactive tag and injected into the body, which is approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors. The study will see how the tracer is taken up in your heart before and after treatment using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). Investigators are doing this research study to find out if DOTATATE can help doctors diagnose people with cardiac (heart) sarcoidosis better as well as serve as a follow-up monitoring tool for a response to therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-20
• Study Start: 2018-12-01
• Status Verified: 2022-12
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Suspected Cardiac Sarcoidosis	Gallium-68 DOTATATE	patients with biopsy proven or suspected sarcoidosis (based on standard clinical imaging findings).

Primary Outcome Measures

Name	Time	Method
Dotatate SUVmax activity in the heart	3 years	The standardized uptake value (SUV) is a nuclear medicine unit commonly used to distinguish between "normal" and "abnormal" levels of tissue uptake.

Secondary Outcome Measures

Name	Time	Method
Change in Dotatate SUVmax activity in the heart on follow-up PET/CT scan compared to baseline	3 years	Dotatate activity (in SUVmax units) in the heart will be measured at baseline and then again at least 3 months after immunotherapy initiation in subjects with suspected cardiac sarcoidosis

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States