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

NCT01296139 | Completed Phase 1

• 2 other identifiers: 11009811-C-0098
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Non-Cutaneous Malignancy; Prostatectomy; Metastatic Prostate Cancer; Imaging Study; Magnetic Resonance Imaging; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Optimal dose of Ferumoxytol for enhancing lymph nodes

  48 hours

Study Arms (1)

A

EXPERIMENTAL

All subjects will receive 7.5 mg/kg Fe

Drug: Ferumoxytol

Interventions

Ferumoxytol DRUG

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.

A

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Li W, Tutton S, Vu AT, Pierchala L, Li BS, Lewis JM, Prasad PV, Edelman RR. First-pass contrast-enhanced magnetic resonance angiography in humans using ferumoxytol, a novel ultrasmall superparamagnetic iron oxide (USPIO)-based blood pool agent. J Magn Reson Imaging. 2005 Jan;21(1):46-52. doi: 10.1002/jmri.20235.

  PMID: 15611942 BACKGROUND

• Li W, Salanitri J, Tutton S, Dunkle EE, Schneider JR, Caprini JA, Pierchala LN, Jacobs PM, Edelman RR. Lower extremity deep venous thrombosis: evaluation with ferumoxytol-enhanced MR imaging and dual-contrast mechanism--preliminary experience. Radiology. 2007 Mar;242(3):873-81. doi: 10.1148/radiol.2423052101.

  PMID: 17325072 BACKGROUND

• Neuwelt EA, Varallyay CG, Manninger S, Solymosi D, Haluska M, Hunt MA, Nesbit G, Stevens A, Jerosch-Herold M, Jacobs PM, Hoffman JM. The potential of ferumoxytol nanoparticle magnetic resonance imaging, perfusion, and angiography in central nervous system malignancy: a pilot study. Neurosurgery. 2007 Apr;60(4):601-11; discussion 611-2. doi: 10.1227/01.NEU.0000255350.71700.37.

  PMID: 17415196 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Peter L Choyke, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2011
• First Posted: February 15, 2011
• Study Start: January 26, 2011
• Primary Completion: March 19, 2015
• Study Completion: March 19, 2015
• Last Updated: July 5, 2018

Record last verified: 2015-03-19

Locations

US (1)