NCT00087347

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

July 8, 2004

Last Update Submit

May 12, 2013

Conditions

Breast CancerProstate Cancer

Keywords

recurrent prostate cancerstage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent breast cancer

Interventions

ferumoxytolDRUG
magnetic resonance imagingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 18084623RESULT

MeSH Terms

Conditions

Breast NeoplasmsProstatic Neoplasms

Interventions

Ferrosoferric OxideMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsFerrous CompoundsMineralsSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Mukesh Harisinghani, MD

    Massachusetts General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

September 1, 2004

Primary Completion

September 1, 2006

Last Updated

May 14, 2013

Record last verified: 2013-05

Locations

US(1)