Prostate Cancer
Evaluation of Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer
NCI-11-C-0098, NCT01296139
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Investigator(s): |
Peter Choyke, M.D., F.A.C.R. Principal Investigator Phone: 301-402-8409 Fax: 301-402-3191 pchoyke@mail.nih.gov
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Yolanda McKinney, R.N., B.S.N. Research Nurse Phone: 301-443-6913 ymckinney@mail.nih.gov
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Key Eligibility Criteria:
- Diagnosis of prostate cancer
- Scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center
- ECOG ≤ 2
- No hypersensitivity or allergy to iron
- Able to undergo magnetic resonance imaging (MRI) (no severe claustrophobia unresponsive to oral anxiolytics; no pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI)
- Weight ≤ 300lb (136 kg)
Study Outline:
- Screening with a full physical examination and medical history, blood and tumor samples and imaging studies to evaluate eligibility for study participation
- Magnetic resonance imaging (MRI) scan to provide baseline images for the study
- Injection of ferumoxytol and will return for another MRI scan on the following day (around 24 hours later)
- Some participants may have an optional third MRI scan 48 hours after the initial injection of ferumoxytol
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 9/12/12
Updated: 10/11/11