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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can help doctors diagnose people with cardiac sarcoidosis better.
OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indium-111 Pentreotide (OctreoScan) | Experimental | 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 | Experimental | 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 1 hour after injection for DOTATATE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indium-111 Pentreotide | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Characterized by Abnormal or Negative Uptake | To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Treatment | To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants Characterized by Abnormal or Negative Uptake | To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies. | 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. | Posted | Count of Participants | Participants | 1 hour |
|
Adverse events were collected until up to 4 days after the last visit. One subject completed the optional Study Day 2 visit, so adverse events were collected up to 6 months after consent.
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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 | 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. |
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Limitations include small sample size (we only included individuals with myocardial FDG uptake) and there is no gold standard for the diagnosis of inflammation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paco Bravo, MD | University of Pennslyvania | 1-215-220-9494 | Paco.Bravo@pennmedicine.upenn.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 13, 2017 | Jan 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| ID | Term |
|---|---|
| C081788 | pentetreotide |
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| Gallium-68 DOTATATE |
| Drug |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
|
|
| Secondary | Effect of Treatment | To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies. | Only one patient underwent a repeat Dotatate PET/CT scan to investigate treatment response in our study | Posted | Count of Participants | Participants | 1 hour |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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 or Gallium-68 DOTATATE. The imaging protocol will consist of imaging at 1 hour after injection for DOTATATE. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |