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Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

Primary Purpose

Sarcoidosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indium-111 Pentreotide
Gallium-68 DOTATATE
Sponsored by
Marcelo F. Di Carli, MD, FACC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals aged 18 or older
  • Documentation of biopsy-proven sarcoidosis OR patients with typical findings on FDG PET and MRI without previous biopsy
  • Clinical suspicion of cardiac involvement defined as the presence of any of the following: high-degree A-V nodal block, complete bundle branch block, reduced left or right ventricular systolic function, any cardiac arrhythmia, and/or unexplained chest pain, dyspnea or syncope
  • PET/CT imaging demonstrating abnormal myocardial FDG uptake consistent with active inflammatory myocardium.

Exclusion Criteria:

  • Initiation of steroids or any other immunosuppressive medication(s) following the completion of FDG-PET, as these medications, in theory, may subsequently suppress OctreoScan or DOTATATE uptake in the heart.
  • Patients with history of neuroendocrine tumors (specially insulinomas)
  • Patients taking the medication Octreotide
  • Patients on total parenteral nutrition (TPN)
  • Women who are pregnant or breastfeeding

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Indium-111 Pentreotide (OctreoScan)

Gallium-68 DOTATATE

Arm Description

Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Indium-111 Pentreotide (OctreoScan). The imaging protocol will consist of imaging at 4 and 24 hours after OctreoScan injection.

Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Gallium-68 DOTATATE. The imaging protocol will consist of imaging 1 hour after injection for DOTATATE.

Outcomes

Primary Outcome Measures

Number of Participants Characterized by Abnormal or Negative Uptake
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.

Secondary Outcome Measures

Effect of Treatment
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.

Full Information

First Posted
September 9, 2015
Last Updated
April 2, 2020
Sponsor
Marcelo F. Di Carli, MD, FACC
Collaborators
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT02546388
Brief Title
Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
Official Title
Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marcelo F. Di Carli, MD, FACC
Collaborators
Mallinckrodt

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can help doctors diagnose people with cardiac sarcoidosis better. OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indium-111 Pentreotide (OctreoScan)
Arm Type
Experimental
Arm Description
Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Indium-111 Pentreotide (OctreoScan). The imaging protocol will consist of imaging at 4 and 24 hours after OctreoScan injection.
Arm Title
Gallium-68 DOTATATE
Arm Type
Experimental
Arm Description
Patients with biopsy-proven extra-cardiac sarcoidosis OR atypical findings on FDG PET and MRI without previous biopsy will be recruited to receive an injection of the FDA-approved radiotracer Gallium-68 DOTATATE. The imaging protocol will consist of imaging 1 hour after injection for DOTATATE.
Intervention Type
Drug
Intervention Name(s)
Indium-111 Pentreotide
Other Intervention Name(s)
OctreoScan
Intervention Type
Drug
Intervention Name(s)
Gallium-68 DOTATATE
Primary Outcome Measure Information:
Title
Number of Participants Characterized by Abnormal or Negative Uptake
Description
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Effect of Treatment
Description
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals aged 18 or older Documentation of biopsy-proven sarcoidosis OR patients with typical findings on FDG PET and MRI without previous biopsy Clinical suspicion of cardiac involvement defined as the presence of any of the following: high-degree A-V nodal block, complete bundle branch block, reduced left or right ventricular systolic function, any cardiac arrhythmia, and/or unexplained chest pain, dyspnea or syncope PET/CT imaging demonstrating abnormal myocardial FDG uptake consistent with active inflammatory myocardium. Exclusion Criteria: Initiation of steroids or any other immunosuppressive medication(s) following the completion of FDG-PET, as these medications, in theory, may subsequently suppress OctreoScan or DOTATATE uptake in the heart. Patients with history of neuroendocrine tumors (specially insulinomas) Patients taking the medication Octreotide Patients on total parenteral nutrition (TPN) Women who are pregnant or breastfeeding
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

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