PET Imaging in Patients With Suspected Cardiac Sarcoidosis

Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Sarcoidosis
• Intervention / Treatment: Drug: Gallium-68 DOTATATE

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Suspected Cardiac Sarcoidosis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Suspected Cardiac Sarcoidosis; patients with biopsy proven or suspected sarcoidosis (based on standard clinical imaging findings).	Drug: Gallium-68 DOTATATE; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dotatate SUVmax activity in the heart on follow-up PET/CT scan compared to baseline	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	3 years

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Advanced Accelerator Applications

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Sarcoidosis
• Other Study ID Numbers: 829715

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No