Magnetic Resonance Imaging of Lymph Nodes Using Ferumoxytol in Patients With Primary Prostate or Breast Cancer

NCT ID: NCT00087347

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-09-30

Brief Summary

RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) using ferumoxytol may improve the ability to detect cancer that has spread to the lymph nodes and may help plan effective cancer treatment.

PURPOSE: This clinical trial is studying how well MRI using ferumoxytol works in detecting metastases to the lymph nodes in patients with primary prostate cancer or primary breast cancer.

Detailed Description

OBJECTIVES:

Primary

• Determine the range of optimal timing for magnetic resonance imaging of lymph nodes after administration of ferumoxytol, in terms of assessing signal intensity using pre-defined pulse sequences in regions of interest and visual criteria, in patients with primary prostate or breast cancer who are scheduled to undergo surgical lymph node dissection or sampling.

Secondary

• Correlate MRI signal intensity with histological findings in patients undergoing this procedure.

OUTLINE: This is an open-label, pilot study.

Patients undergo a baseline MRI. Within 24 hours after the baseline MRI, patients receive ferumoxytol IV over 10-15 seconds (or over 1 hour). Patients then undergo MRI immediately after ferumoxytol administration (at the discretion of the principal investigator) and then at 24-28 hours.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 10-14 patients (6-8 with prostate cancer and 4-6 with breast cancer) will be accrued for this study.

Conditions

Breast Cancer; Prostate Cancer

Interventions

ferumoxytol

Intervention Type: DRUG

magnetic resonance imaging

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary prostate or breast cancer
• Suspected lymph node metastatic disease by standard MRI or CT scan
• Scheduled for surgical lymph node dissection or sampling
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Not specified

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• No prior ferritin > 800 ng/mL
• No prior transferrin saturation > 60%
• No history of iron overload or hemachromatosis

• Patients with a clinical history of suspected iron overload or hemachromatosis must have normal serum iron, ferritin, and transferrin saturation

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• SGOT ≤ 2 times ULN

Renal

• Not specified

Other

• No requirement for monitored anesthesia during MRI
• No known allergic or hypersensitivity reaction to any of the following parenterally-administered preparations:

• Iron
• Dextran
• Iron dextran
• Iron polysaccharide
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception for at least 1 month before and during study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior therapy for metastatic disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mukesh Harisinghani, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mukesh Harisinghani, MD

Role: STUDY_CHAIR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

References

Harisinghani M, Ross RW, Guimaraes AR, Weissleder R. Utility of a new bolus-injectable nanoparticle for clinical cancer staging. Neoplasia. 2007 Dec;9(12):1160-5. doi: 10.1593/neo.07940.

Reference Type: RESULT

PMID: 18084623 (View on PubMed)

Other Identifiers

MGH-2004-P-000681/2

Identifier Type: -

Identifier Source: secondary_id

NCI-6809

Identifier Type: -

Identifier Source: secondary_id

CDR0000374491

Identifier Type: -

Identifier Source: org_study_id