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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). 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 |
What the finished NCT01296139 record still lists
NCT01296139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Ferumoxytol is the first listed.
NCT01296139 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01296139's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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