68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer
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- STATUS
- Recruiting
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- End date
- Jul 27, 2023
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- participants needed
- 90
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- sponsor
- Andrei Iagaru
Summary
This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed tomography (CT) works in detecting regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller tumors than the standard of care CT or magnetic resonance imaging scan.
Description
PRIMARY OBJECTIVES:
I. To evaluate 68Ga-RM2 PET/CT for detection of intermediate and high-risk prostate cancer prior to prostatectomy.
- OUTLINE
Patients receive 68Ga-RM2 intravenously (IV). Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.
After completion of study, patients are followed up at 24-48 hours and within 3-12 months.
Details
| Condition | Stage II Prostate Adenocarcinoma, Stage III Prostate Adenocarcinoma, Stage IV Prostate Adenocarcinoma |
|---|---|
| Treatment | laboratory biomarker analysis, computed tomography, positron emission tomography, Gallium Ga 68-labeled GRPR Antagonist BAY86-7548 |
| Clinical Study Identifier | NCT03113617 |
| Sponsor | Andrei Iagaru |
| Last Modified on | 25 February 2022 |
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