Completed

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

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What is being collected

Data Collection

Who is being recruted

Urogenital Diseases
+10

+ Genital Diseases
+ Breast Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: September 2004
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleAn 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 
NCT00087347
Principal SponsorMassachusetts General Hospital
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
14 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Genital Diseases
Breast Diseases
Breast Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Prostatic Neoplasms
Skin Diseases
Urogenital Neoplasms
Male Urogenital Diseases
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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Massachusetts General Hospital Cancer CenterBoston, United StatesSee the location
CompletedOne Study Center