Trial Outcomes & Findings for Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis (NCT NCT02546388)
NCT ID: NCT02546388
Last Updated: 2020-04-09
Results Overview
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
1 hour
Results posted on
2020-04-09
Participant Flow
Participant milestones
| Measure |
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.
|
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 at 1 hour after injection for DOTATATE.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
13
|
|
Overall Study
COMPLETED
|
4
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
Baseline characteristics by cohort
| Measure |
Indium-111 Pentreotide (OctreoScan)
n=4 Participants
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.
|
Gallium-68 DOTATATE
n=13 Participants
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
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Continuous
|
62 Years
n=99 Participants
|
59 Years
n=107 Participants
|
60 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
13 participants
n=107 Participants
|
17 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: 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.
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.
Outcome measures
| Measure |
Gallium-68 DOTATATE
n=13 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants Characterized by Abnormal or Negative Uptake
Number of Subjects with Definitely Abnormal Uptake
|
4 Participants
|
—
|
|
Number of Participants Characterized by Abnormal or Negative Uptake
Number of Subjects with Probably Abnormal Uptake
|
3 Participants
|
—
|
|
Number of Participants Characterized by Abnormal or Negative Uptake
Number of Subjects with Negative Uptake
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 hourPopulation: Only one patient underwent a repeat Dotatate PET/CT scan to investigate treatment response in our study
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.
Outcome measures
| Measure |
Gallium-68 DOTATATE
n=1 Participants
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.
|
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.
|
|---|---|---|
|
Effect of Treatment
Number of Subjects wPositive Response to Treatment
|
1 Participants
|
—
|
|
Effect of Treatment
Number of Subjects wNegative Response to Treatment
|
0 Participants
|
—
|
Adverse Events
Indium-111 Pentreotide (OctreoScan)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gallium-68 DOTATATE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place