Cardiac Sarcoidosis
Conditions
Brief summary
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.
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.
Interventions
5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.
DRUG18FDG 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.
DRUG13NH3 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS) | 3 days | The number of subjects with areas of abnormal myocardial increased focal uptake |
| 18FDG Uptake With Cardia Sarcoidosis (CS) | 2 days | The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan |
| 13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS) | 2 days | The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Confidence in Study Interpretation | 2 days | 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 |
| Subject Satisfaction | 2 days | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 68Ga-DOTATATE PET/CT 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | 68Ga-DOTATATE PET/CT |
|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 1 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan
Time frame: 2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 68Ga-DOTATATE PET/CT | 13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS) | 8 Participants |
Primary
18FDG Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan
Time frame: 2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 68Ga-DOTATATE PET/CT | 18FDG Uptake With Cardia Sarcoidosis (CS) | 9 Participants |
Primary
68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS)
The number of subjects with areas of abnormal myocardial increased focal uptake
Time frame: 3 days
Population: Unreliable or uninterpretable data due to background uptake on 68Ga-DOTATATE scans. Data not obtained and was not analyzed
Secondary
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
Time frame: 2 days
Population: Unreliable or uninterpretable data due to background uptake on 68Ga-DOTATATE scans. Data unable to obtain and was not analyzed
Secondary
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
Time frame: 2 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 68Ga-DOTATATE PET/CT | Subject Satisfaction | 18FDG | 0 Participants |
| 68Ga-DOTATATE PET/CT | Subject Satisfaction | 68GA-DOTATATE | 13 Participants |
| 68Ga-DOTATATE PET/CT | Subject Satisfaction | Equal | 2 Participants |