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NCT01296139 · ClinicalTrials.gov registry record · Phase 1
Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01296139: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01296139 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01296139, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Background: \- Ferumoxytol is an approved iron replacement therapy agent that has some potential for use as a contrast agent in imaging studies of the lymph system, especially involving lymph nodes that have been affected by cancer. Ferumoxytol is taken up by normal lymph nodes, but excluded from cancerous lymph node tissue. Because Ferumoxytol has not yet been approved for use as an imaging agent, researchers are interested in testing its effectiveness as a contrast agent for studies of normal lymph tissue and cancer tissue in lymph nodes of individuals with prostate cancer. Objectives: \- To evaluate the safety and effectiveness of Ferumoxytol as a contrast agent in individuals who are scheduled to have prostate removal surgery to treat prostate cancer. Eligibility: \- Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled to have surgery to remove the prostate and surrounding lymph nodes. Design: * Participants will be screened with a full medical history and physical examination, blood and urine tests, and tumor imaging studies. * Participants will have a magnetic resonance imaging (MRI) scan to provide baseline images for the study. * Participants will receive an injection of Ferumoxytol and will return for another MRI scan on the following day (around 24 hours later). * Some participants may have a third MRI scan 48 hours after the initial injection of Ferumoxytol. This third MRI scan is optional and not required by the study. * Although the scanning and followup portion of the study will last only a few days, participants will be considered to be enrolled on the study until after the prostate removal surgery.
Interventions
- DRUG Ferumoxytol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-01-26 |
| Est. Completion | 2015-03-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01296139
The ClinicalTrials.gov registry entry for NCT01296139 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ferumoxytol is the first listed.
NCT01296139 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01296139 about?
NCT01296139 is a clinical study titled "Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer". Background: \- Ferumoxytol is an approved iron replacement therapy agent that has some potential for use as a contrast agent in imaging studies of the lymph system, especially involving lymph nodes that have been affected by cancer. Ferumoxytol is taken up by normal lymph nodes, but excluded from c...
What is the current status of trial NCT01296139?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2011-01-26. Estimated completion is 2015-03-19.
What interventions are being tested in trial NCT01296139?
The interventions under investigation include: Ferumoxytol (DRUG).
Who is sponsoring clinical trial NCT01296139?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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