Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02043522 | 123I-mIBG SPECT Imaging | PHASE3 | COMPLETED | 30 | — | — | Dec 1, 2013 | Nov 1, 2015 | Apr 24, 2017 | 1 | Canada |
Measurements of heart to calibration ratios (HCR) in a phantom model with planar, conventional SPECT and CZT SPECT imaging will be compared between the modalities and used to set up the imaging process; Measurements of heart to mediastinum (H/M) ratios with planar, conventional SPECT and CZT SPECT imaging in participants from three specific populations on all sets of images will be compared.
| Arm | Type | Description |
|---|---|---|
| Nuclear Imaging | EXPERIMENTAL | Planar, conventional SPECT imaging and CZT SPECT imaging will be done. Imaging will begin immediately following radioisotope injection with CZT SPECT imaging for 15 minutes, followed by 1) planar anterior view imaging for 10 minutes, 2) conventional SPECT imaging for 12.5 minutes and 3) CZT SPECT imaging for 12 minutes. A low dose CT transmission scan will be acquired for attenuation correction (GE Infinia Hawkeye) with the initial conventional SPECT imaging and not repeated with subsequent imaging. Participants will undergo repeat imaging at 1, 2, 3 and 4 hours after radiotracer injection with each imaging session to include 1) planar anterior, 2) conventional SPECT and 3) CZT SPECT imaging. |
| Name | Type | Description |
|---|---|---|
| Radioisotope | DRUG | One dose of 10 mCi (370 mBq:± 10%, calibrated to time of injection) of 123I-mIBG (AdreView) administered as a single intravenous bolus over 1 or 2 minutes, followed by a saline flush. |
Inclusion Criteria: For all participants: 1. Male or female ≥ 18 years at study entry. 2. Able and willing to comply with the study procedures. 3. Written informed consent. 4. Female subjects must be post-menopausal, surgically sterilized or have negative serum beta human chorionic gonadotropin pr...