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

Primary Purpose

Breast Cancer, Prostate Cancer

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
ferumoxytol
magnetic resonance imaging
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2004
Last Updated
May 12, 2013
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00087347
Brief Title
Magnetic Resonance Imaging of Lymph Nodes Using Ferumoxytol in Patients With Primary Prostate or Breast Cancer
Official Title
An NCI-Sponsored Exploratory Study For Determining Optimum Timing For The Imaging Of Intravenous Superparamagnetic Particle Ferumoxytol (Code7228) For The Differentiation of Metastatic and Non Metastatic Lymph Nodes in Patients With Known Primary Cancer Scheduled For Possible Surgical Lymph Node Biopsy/Dissection
Study Type
Observational

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer
Keywords
recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer

7. Study Design

Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ferumoxytol
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mukesh Harisinghani, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18084623
Citation
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.
Results Reference
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Magnetic Resonance Imaging of Lymph Nodes Using Ferumoxytol in Patients With Primary Prostate or Breast Cancer

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