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Radioisotope · 1 trial · 2 indications
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...
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Radioisotope is an investigational small molecule being studied for use in heart failure and coronary artery disease. It is a diagnostic imaging agent evaluated in a Phase 3 clinical trial for cardiac imaging. The drug is not approved and remains in clinical development.
Radioisotope is a small molecule imaging agent used in cardiac scintigraphy. It is designed to visualize cardiac sympathetic innervation, helping assess heart failure and coronary artery disease. The specific molecular target is not disclosed in available information.
Radioisotope is being developed by GE HealthCare Technologies Inc., traded on the NYSE under the ticker GEHC. The company is conducting clinical research on this diagnostic imaging agent for cardiovascular applications.
Radioisotope is in Phase 3 clinical development. A Phase 3 trial has been completed, but the drug remains investigational and has not received FDA approval. It is still undergoing clinical evaluation for heart failure and coronary artery disease.
Radioisotope has one completed Phase 3 trial, NCT02043522, titled '123I-mIBG SPECT Imaging'. This study enrolled 30 participants in Canada and evaluated the drug in heart failure and coronary artery disease patients. The trial was uncontrolled and not blinded.