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NCT01176513 · ClinicalTrials.gov registry record · Phase 2
GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer
A Phase 2 study, sponsored by GE Healthcare.
- Terminated
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01176513 is a Phase 2 study that was terminated before completion, run by GE Healthcare. The registered enrollment target is 25 participants.
The verdict
NCT01176513, a Phase 2 study, was terminated before completion, sponsored by GE Healthcare.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
Background: \- GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells. Researchers are interested in combining the drug with a small amount of radioactive material to allow prostate cancer lesions to appear more clearly on imaging scans. Researchers are also interested in determining whether the combination can help make cancer cells in pelvic lymph nodes easier to detect through imaging studies. GE-148 (18F) will be used to examine individuals who are scheduled to have surgery on their prostate cancer. Objectives: \- To evaluate the effectiveness of GE-148 (18F) in detecting prostate cancer and cancer cells in pelvic lymph nodes using positron emission tomography and magnetic resonance imaging scanning. Eligibility: \- Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled to have prostate removal surgery. Design: * Participants will be screened with a physical examination, medical history, blood tests, and imaging studies. * Participants will have magnetic resonance imaging (MRI) and positron emission tomography (PET) scans with GE-148 (18F) prior to their scheduled surgery. The MRI and PET scans may be performed on the same day or on different days, depending on the schedule set by the study researchers. * Tissue samples taken during prostate removal surgery, including prostate tissue and pelvic lymph nodes, will be collected for further study of the effectiveness of GE-148 (18F).
Interventions
- DRUG GE-148 (18F)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01176513
The ClinicalTrials.gov registry entry for NCT01176513 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GE-148 (18F) is the first listed.
NCT01176513 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01176513 about?
NCT01176513 is a clinical study titled "GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer". Background: \- GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells. Researchers are interested in combining the drug with a small amount of radioactive material to allow prostate cancer lesions to appear more clearly on imaging scans. Researchers are also interested in de...
What is the current status of trial NCT01176513?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2010-07. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01176513?
The interventions under investigation include: GE-148 (18F) (DRUG).
Who is sponsoring clinical trial NCT01176513?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
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