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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01296139
First received: February 12, 2011
Last updated: June 10, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention Phase
Prostate Cancer
Drug: Ferumoxytol
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Optimal dose of Ferumoxytol for enhancing lymph nodes [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: January 2011
Study Completion Date: June 2014
Arms Assigned Interventions
Experimental: A
All subjects will receive 7.5 mg/kg Fe
Drug: Ferumoxytol
All subjects will undergo pre-injection, 24, 48 hours post-Ferumoxytol injection (dose of 7.5mg/kg Fe) MRI consisting of T1 weighted (W), T2W and T2*W MRI in a 3 Tesla magnet. Additionally, all subjects will undergo pre-injection, 24 hours, 48 hours post-Ferumoxytol injection (dose of 7.5mg/kg Fe) ultrasound.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296139

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Peter L Choyke, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01296139     History of Changes
Other Study ID Numbers: 110098, 11-C-0098
Study First Received: February 12, 2011
Last Updated: June 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Non-Cutaneous Malignancy
Prostatectomy
Metastatic Prostate Cancer
Imaging Study
Magnetic Resonance Imaging
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Ferumoxytol
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014