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d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03549598
Recruitment Status : Completed
First Posted : June 8, 2018
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
John P. Bois, M.D., Mayo Clinic

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Cardiac Sarcoidosis
Interventions Drug: 68Ga-DOTATATE PET/CT
Drug: 18FDG PET/CT scan
Drug: 13NH3 PET/CT scan
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 68Ga-DOTATATE PET/CT
Hide Arm/Group Description

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject

68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.

18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.

13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.

Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title 68Ga-DOTATATE PET/CT
Hide Arm/Group Description

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject

68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.

18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.

13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
70  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
3
  20.0%
Male
12
  80.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   6.7%
White
14
  93.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title 68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)
Hide Description The number of subjects with areas of abnormal myocardial increased focal uptake
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Unreliable or uninterpretable data due to background uptake on 68Ga-DOTATATE scans. Data not obtained and was not analyzed
Arm/Group Title 68Ga-DOTATATE PET/CT
Hide Arm/Group Description:

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject

68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.

18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.

13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title 18FDG Uptake With Cardia Sarcoidosis (CS)
Hide Description The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 68Ga-DOTATATE PET/CT
Hide Arm/Group Description:

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject

68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.

18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.

13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
9
  60.0%
3.Primary Outcome
Title 13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)
Hide Description The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 68Ga-DOTATATE PET/CT
Hide Arm/Group Description:

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject

68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.

18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.

13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
8
  53.3%
4.Secondary Outcome
Title Physician Confidence in Study Interpretation
Hide Description 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
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
Unreliable or uninterpretable data due to background uptake on 68Ga-DOTATATE scans. Data unable to obtain and was not analyzed
Arm/Group Title 68Ga-DOTATATE PET/CT
Hide Arm/Group Description:

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject

68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.

18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.

13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Subject Satisfaction
Hide Description 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
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 68Ga-DOTATATE PET/CT
Hide Arm/Group Description:

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject

68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.

18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.

13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
18FDG
0
   0.0%
68GA-DOTATATE
13
  86.7%
Equal
2
  13.3%
Time Frame Adverse events were collected from baseline to through end of study (completion of last scan), approximately 3 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 68Ga-DOTATATE PET/CT 18FDG PET/CT 13NH3 PET/CT"
Hide Arm/Group Description

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject

68Ga-DOTATATE PET/CT: 5.4 mCi of 68Ga-DOTATATE were administered by intravenous route.

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject

18FDG PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 18FDG was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also performed as part of the examination per institutional protocol.

68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan were be performed on each subject

13NH3 PET/CT scan: This scan was performed as part of the planned clinical care for each subject. Dose of 13NH3 was administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan was also be performed as part of this examination per institutional protocol.

All-Cause Mortality
68Ga-DOTATATE PET/CT 18FDG PET/CT 13NH3 PET/CT"
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
68Ga-DOTATATE PET/CT 18FDG PET/CT 13NH3 PET/CT"
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
68Ga-DOTATATE PET/CT 18FDG PET/CT 13NH3 PET/CT"
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      0/15 (0.00%)      0/15 (0.00%)    
Gastrointestinal disorders       
Nausea   1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Indicates events were collected by systematic assessment
Unreliable or uninterpretable data due to background uptake on 68Ga-DOTATATE scans
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John P. Bois, M.D.
Organization: Mayo Clinic
Phone: 507-284-3545
EMail: Bois.John@mayo.edu
Layout table for additonal information
Responsible Party: John P. Bois, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT03549598    
Other Study ID Numbers: 18-000393
First Submitted: May 25, 2018
First Posted: June 8, 2018
Results First Submitted: September 3, 2020
Results First Posted: October 20, 2020
Last Update Posted: October 20, 2020