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Also known as Bombesin (68Ga) labeled (BAY86-7548)
Bombesin labeled · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bombesin (68Ga) labeled (BAY86-7548) | DRUG | Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT |
Inclusion Criteria: * Healthy volunteers: * males, \>/=50 and \</= 65 years of age * Cancer patients: * males \>/= 45 years of age * Patients had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary ...
Bombesin labeled is an investigational diagnostic imaging agent being studied for PET/CT imaging in patients with prostate cancer. It is designed to help visualize prostate cancer tissue during imaging procedures. It is not a treatment for prostate cancer; it is a diagnostic tool intended to support detection and evaluation.
Bombesin labeled is being developed by Lantheus Holdings, Inc., which trades under the ticker LNTH. The company is the sponsor of the clinical program evaluating this imaging agent. Development is at the Phase 1 stage, with one completed trial conducted in Finland, Germany, and Switzerland.
Bombesin labeled is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study enrolled 19 participants and evaluated PET/CT imaging, radiation dosimetry, plasma pharmacokinetics, biodistribution, safety, tolerability, and diagnostic performance in patients with prostate cancer and healthy volunteers.
Bombesin labeled has been studied in one completed Phase 1 trial, NCT01205321. The trial was titled PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers. It enrolled 19 participants across Finland, Germany, and Switzerland and included male participants aged 45 years and older.
Yes. Bombesin labeled is also known as Bombesin (68Ga) labeled, or BAY86-7548. These names refer to the same investigational diagnostic imaging agent developed by Lantheus Holdings, Inc. The BAY86-7548 designation appears in the title of its completed Phase 1 PET/CT imaging trial, NCT01205321.