Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis

• Sponsor: Marcelo F. Di Carli, MD, FACC (Other)
• Overall Status: Completed
• CT.gov ID: NCT02546388
• Collaborator: Mallinckrodt (Industry)
• Enrollment: 17
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoidosis	Drug: Indium-111 Pentreotide; Drug: Gallium-68 DOTATATE	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Indium-111 Pentreotide (OctreoScan) 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.	Drug: Indium-111 Pentreotide; Other Names: OctreoScan
Experimental: Gallium-68 DOTATATE 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.	Drug: Gallium-68 DOTATATE

Outcome Measures

Primary Outcome Measures

1. Number of Participants Characterized by Abnormal or Negative Uptake [1 hour]

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

Secondary Outcome Measures

1. Effect of Treatment [1 hour]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Marcelo F. Di Carli, MD, FACC
• Mallinckrodt

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 13, 2017

More Information

Publications

None provided.

• Responsible Party: Marcelo F. Di Carli, MD, FACC, Chief of Nuclear Medicine, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02546388
• Other Study ID Numbers: 2015P001421
• First Posted: Sep 10, 2015
• Last Update Posted: Apr 9, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Sarcoidosis

Study Results

Participant Flow

Arm/Group Title	Indium-111 Pentreotide (OctreoScan)	Gallium-68 DOTATATE
Arm/Group 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 at 1 hour after injection for DOTATATE.
Period Title: Overall Study
STARTED	4	13
COMPLETED	4	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Indium-111 Pentreotide (OctreoScan)	Gallium-68 DOTATATE	Total
Arm/Group 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 at 1 hour after injection for DOTATATE.	Total of all reporting groups
Overall Participants	4	13	17
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 75%	8 61.5%	11 64.7%
>=65 years	1 25%	5 38.5%	6 35.3%
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	62	59	60
Sex: Female, Male (Count of Participants)
Female	3 75%	2 15.4%	5 29.4%
Male	1 25%	11 84.6%	12 70.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	4 100%	13 100%	17 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 25%	0 0%	1 5.9%
White	3 75%	13 100%	16 94.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%	13 100%	17 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

We initially planned to do OctreoScan, but Dotatate became FDA approved in the process. Due to the superior image quality, lower radiation, and shorter protocol for Dotatate, we decided to abandon OctreoScan.

Arm/Group Title	Gallium-68 DOTATATE	Indium-111 Pentreotide (OctreoScan)
Arm/Group 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 at 1 hour after injection for DOTATATE.	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.
Measure Participants	13	0
Number of Subjects with Definitely Abnormal Uptake	4 100%
Number of Subjects with Probably Abnormal Uptake	3 75%
Number of Subjects with Negative Uptake	6 150%

2. Secondary Outcome

Title	Effect of Treatment
Description	To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

Only one patient underwent a repeat Dotatate PET/CT scan to investigate treatment response in our study

Arm/Group Title	Participants With a Positive or Negative Response to Treatment
Arm/Group 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) or Gallium-68 DOTATATE. The imaging protocol will consist of imaging at 1 hour after injection for DOTATATE.
Measure Participants	1
Number of Subjects wPositive Response to Treatment	1 25%
Number of Subjects wNegative Response to Treatment	0 0%

Adverse Events

Time Frame	Adverse events were collected until up to 4 days after the last visit. One subject completed the optional Study Day 2 visit, so adverse events were collected up to 6 months after consent.
Arm/Group Title	Indium-111 Pentreotide (OctreoScan)		Gallium-68 DOTATATE
Arm/Group 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 or Gallium-68 DOTATATE. The imaging protocol will consist of imaging at 1 hour after injection for DOTATATE.
All Cause Mortality
	Indium-111 Pentreotide (OctreoScan)		Gallium-68 DOTATATE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/13 (0%)
Serious Adverse Events
	Indium-111 Pentreotide (OctreoScan)		Gallium-68 DOTATATE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Indium-111 Pentreotide (OctreoScan)		Gallium-68 DOTATATE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/13 (0%)

Limitations/Caveats

Limitations include small sample size (we only included individuals with myocardial FDG uptake) and there is no gold standard for the diagnosis of inflammation.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.