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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: Clinical Trial Phase 2 study, sponsored by GE Healthcare.
NCT01176513 is a Phase 2 study that was terminated before completion, run by GE Healthcare. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.
Interventions
- DRUG GE-148 (18F)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
Why NCT01176513 stopped before completion
NCT01176513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which GE-148 (18F) is the first listed.
NCT01176513 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01176513's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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