d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so without the need for complex patient dietary preparation that is required with 18FDG PET/CT.

Study Overview

• Status: Completed
• Conditions: Cardiac Sarcoidosis
• Intervention / Treatment: Drug: 68Ga-DOTATATE PET/CT; Drug: 18FDG PET/CT scan; Drug: 13NH3 PET/CT scan

Detailed Description

Prospective study of 15 consecutive patients with suspected or newly diagnosed cardiac sarcoidosis (CS) who are referred for a clinically indicated 18FDG (and 13NH3) PET/CT scan for cardiac sarcoidosis (CS) will be approached to undergo a 68Ga-DOTATATE PET/CT scan. Comparison will then be made between the 68Ga-DOTATATE PET/CT and the 18FDG and 13NH3 PET/CT to determine if 68Ga-DOTATATE detects CS.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)

Exclusion Criteria:

• Pregnant
• Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 68Ga-DOTATATE PET/CT; 68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject

Drug: 68Ga-DOTATATE PET/CT; 5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.; Drug: 18FDG PET/CT scan; This scan will be performed as part of the planned clinical care for the patient. Dose of 18FDG will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.; Drug: 13NH3 PET/CT scan; This scan will be performed as part of the planned clinical care for the patient. Dose of 13NH3 will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)	The number of subjects with areas of abnormal myocardial increased focal uptake	3 days
18FDG Uptake With Cardia Sarcoidosis (CS)	The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan	2 days
13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)	The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Confidence in Study Interpretation	A Physician survey will be conducted for those cardiac imagers assessing both the DOTATATE and FDG studies to determine their confidence level in interpreting the studies and if one study was easier to interpret than the other	2 days
Subject Satisfaction	A patient survey will be conducted after each subject has undergone both the DOTATE and the FDG scans. Patient satisfaction will be measured by the question, "Which study did you prefer?" Subject to circle one of the following: 18FDG, 68Ga-DOTATATE or Equal	2 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: John P Bois, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2018
• Primary Completion (ACTUAL): October 2, 2019
• Study Completion (ACTUAL): October 2, 2019

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (ACTUAL): June 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Sarcoidosis; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 18-000393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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