Sarcoidosis
Conditions
Brief summary
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.
Interventions
DRUGIndium-111 Pentreotide
Sponsors
Mallinckrodt
Marcelo F. Di Carli, MD, FACC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Individuals aged 18 or older * Documentation of biopsy-proven sarcoidosis OR patients with typical findings on FDG PET and MRI without previous biopsy * Clinical suspicion of cardiac involvement defined as the presence of any of the following: high-degree A-V nodal block, complete bundle branch block, reduced left or right ventricular systolic function, any cardiac arrhythmia, and/or unexplained chest pain, dyspnea or syncope * PET/CT imaging demonstrating abnormal myocardial FDG uptake consistent with active inflammatory myocardium.
Exclusion criteria
* Initiation of steroids or any other immunosuppressive medication(s) following the completion of FDG-PET, as these medications, in theory, may subsequently suppress OctreoScan or DOTATATE uptake in the heart. * Patients with history of neuroendocrine tumors (specially insulinomas) * Patients taking the medication Octreotide * Patients on total parenteral nutrition (TPN) * Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Characterized by Abnormal or Negative Uptake | 1 hour | To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Treatment | 1 hour | To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 13 |
| Total | 17 |
Baseline characteristics
| Characteristic | Indium-111 Pentreotide (OctreoScan) | Gallium-68 DOTATATE | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 5 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 8 Participants | 11 Participants |
| Age, Continuous | 62 Years | 59 Years | 60 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 13 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 13 Participants | 16 Participants |
| Region of Enrollment United States | 4 participants | 13 participants | 17 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 11 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 13 |
| other Total, other adverse events | 0 / 4 | 0 / 13 |
| serious Total, serious adverse events | 0 / 4 | 0 / 13 |
Outcome results
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.
Time frame: 1 hour
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gallium-68 DOTATATE | Number of Participants Characterized by Abnormal or Negative Uptake | Number of Subjects with Definitely Abnormal Uptake | 4 Participants |
| Gallium-68 DOTATATE | Number of Participants Characterized by Abnormal or Negative Uptake | Number of Subjects with Probably Abnormal Uptake | 3 Participants |
| Gallium-68 DOTATATE | Number of Participants Characterized by Abnormal or Negative Uptake | Number of Subjects with Negative Uptake | 6 Participants |
Secondary
Effect of Treatment
To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.
Time frame: 1 hour
Population: Only one patient underwent a repeat Dotatate PET/CT scan to investigate treatment response in our study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gallium-68 DOTATATE | Effect of Treatment | Number of Subjects wPositive Response to Treatment | 1 Participants |
| Gallium-68 DOTATATE | Effect of Treatment | Number of Subjects wNegative Response to Treatment | 0 Participants |