Magnetic Resonance Imaging of Lymph Nodes Using Ferumoxytol in Patients With Primary Prostate or Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00087347 |
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Recruitment Status :
Completed
First Posted : July 12, 2004
Last Update Posted : May 14, 2013
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Breast Cancer Prostate Cancer | Drug: ferumoxytol Procedure: magnetic resonance imaging |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 14 participants |
| 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 Start Date : | September 2004 |
| Actual Primary Completion Date : | September 2006 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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%
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087347
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Study Chair: | Mukesh Harisinghani, MD | Massachusetts General Hospital |
Publications of Results:
| Responsible Party: | Mukesh Harisinghani, MD, Associate Professor, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00087347 History of Changes |
| Other Study ID Numbers: |
CDR0000374491 MGH-2004-P-000681/2 NCI-6809 |
| First Posted: | July 12, 2004 Key Record Dates |
| Last Update Posted: | May 14, 2013 |
| Last Verified: | May 2013 |
Keywords provided by Mukesh Harisinghani, MD, Massachusetts General Hospital:
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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 |
Additional relevant MeSH terms:
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Breast Neoplasms Prostatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Ferrosoferric Oxide Hematinics Parenteral Nutrition Solutions Pharmaceutical Solutions |