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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-DOTATATE PET/CT | Experimental | 68Ga-DOTATATE PET/CT scan, 18FDG PET/CT scan and 13NH3 PET/CT scan will be performed on each subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTATATE PET/CT | Drug | 5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Bois | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 68Ga-DOTATATE Uptake With Cardia Sarcoidosis (CS) | The number of subjects with areas of abnormal myocardial increased focal uptake | Unreliable or uninterpretable data due to background uptake on 68Ga-DOTATATE scans. Data not obtained and was not analyzed | Posted | 3 days |
|
Adverse events were collected from baseline to through end of study (completion of last scan), approximately 3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Unreliable or uninterpretable data due to background uptake on 68Ga-DOTATATE scans
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John P. Bois, M.D. | Mayo Clinic | 507-284-3545 | Bois.John@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2018 | Sep 2, 2020 | Prot_SAP_000.pdf |
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| 18FDG PET/CT scan | Drug | 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. |
|
| 13NH3 PET/CT scan | Drug | 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. |
|
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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 18FDG Uptake With Cardia Sarcoidosis (CS) | The number of subjects with areas of abnormal myocardial increased focal uptake on 18FDG scan | Posted | Count of Participants | Participants | 2 days |
|
|
|
| Primary | 13NH3 PET/CT Uptake With Cardia Sarcoidosis (CS) | The number of subjects with areas of perfusion deficits on 13NH3 PET/CT scan | Posted | Count of Participants | Participants | 2 days |
|
|
|
| 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 | Unreliable or uninterpretable data due to background uptake on 68Ga-DOTATATE scans. Data unable to obtain and was not analyzed | Posted | 2 days |
|
|
| 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 | Posted | Count of Participants | Participants | 2 days |
|
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|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | 18FDG PET/CT | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | 13NH3 PET/CT" | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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