Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer

• Status: Completed
• Trial end date: 2015-03-19
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Ferrosoferric Oxide

Criteria

• INCLUSION CRITERIA:

• Subject must be male and be greater than or equal to 18 years old.

• Subject must have a histologically confirmed diagnosis of prostate cancer.

• Subjects enrolling in the lymph node involvement subgroup must have imaging evidence of lymph node involvement (with a size of greater than or equal to 1.5 cm).

• Subject must have Eastern Cooperative Oncology Group Performance score less than or equal to 2.

Subjects in the dose finding cohorts must be scheduled to undergo prostatectomy for presumed prostate cancer.

-Subjects must be scheduled to undergo prostatectomy for presumed prostate cancer

EXCLUSION CRITERIA:

• Subjects with known hypersensitivity and allergy to iron

• Subjects with evidence of iron overload with a pre-study ferritin level greater than 370 ng/ml and percent saturation of transferrin level greater than 40%. Patients with lab values above these limits may be included in the study if documented hematology consultation rules out hemochromatosis.

• Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results

• Subjects with severe claustrophobia unresponsive to oral anxiolytics

• Subjects with contraindications to MRI

• Subjects weighing >136 kg (weight limit for scanner table)

• Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.

• Subjects with abnormal liver function tests suggesting liver dysfunction (AST and ALT >2 times the upper limits of normal; total bilirubin, of >2 times the upper limits of normal or >3.0 mg/dl in patients with Gilbert s syndrome).

• Subjects with other medical conditions deemed by the principle investigator (or associates) or the sponsor to make the subject ineligible for protocol procedures.

INCLUSION OF WOMEN AND MINORITIES:

• Members of all races and ethnic groups are eligible for this trial.

• Women are excluded from this trial as prostate cancer does not occur in females.