Magnetic Resonance Imaging Using Ferumoxytol in Patients With Primary Brain Cancer or Brain Metastases From Lung or Breast Cancer - Full Text View

Sponsors and Collaborators:	OHSU Knight Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00103038

Purpose

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) using ferumoxytol, may help find and diagnose primary brain cancer or brain metastases.

PURPOSE: This randomized clinical trial is studying how well MRI using ferumoxytol works in finding out the extent of the tumor in patients with primary brain cancer or brain metastases from lung or breast cancer.

Condition	Intervention
Brain and Central Nervous System Tumors Breast Cancer Lung Cancer Lymphoma	Drug: ferumoxytol Procedure: magnetic resonance imaging

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	NCI-Sponsored Multidisciplinary Study of Initial Timing of MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol (Code 7228) in Primary High-Grade Brain Tumors and/or Cerebral Metastases From Lung or Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Brain Cancer Breast Cancer Cancer Lung Cancer Lymphoma MRI Scans

Drug Information available for: Ferumoxytol

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Optimum timing and imaging sequences by MRI images periodically after ferumoxytol [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate MR angiography by MRI images done within 72 hours after ferumoxytol [ Designated as safety issue: No ]
Tumor images assessed by MRI images within 72 hours after ferumoxytol [ Designated as safety issue: No ]
Tumor vascularity assessed by MRI images within 72 hours after ferumoxytol [ Designated as safety issue: No ]
Histology and electron microscopy (EM) on tissue samples assessed by laboratory pathology after surgery [ Designated as safety issue: No ]
Compare differences between prior therapy with no therapy by statistical analysis at completion of study [ Designated as safety issue: No ]

Study Start Date:

April 2004

Detailed Description:

OBJECTIVES:

Primary

Determine, preliminarily, the safety and efficacy of magnetic resonance imaging (MRI) using ferumoxytol in patients with primary malignant brain tumors or brain metastases secondary to lung or breast cancer.
Determine, preliminarily, the optimum post-injection timing of ferumoxytol for imaging in these patients.
Determine whether there are major differences in magnetic field strength for imaging in these patients.

Secondary

Compare, preliminarily, ferumoxytol magnetic resonance angiography (MRA) with gadolinium MRA in these patients.
Determine, preliminarily, the number and size of tumors imaged in these patients.
Determine, preliminarily, tumor vascularity in these patients.
Determine, preliminarily, histology and electron microscopy on tissue samples in these patients.
Compare, preliminarily, imaging differences in patients who have received prior therapy vs no prior therapy (radiotherapy and/or chemotherapy).

OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 magnetic field strengths (1.5 Tesla vs 3.0 Tesla) of magnetic resonance angiography (MRA).

Patients receive ferumoxytol IV for up to 1 hour (single or multiple bolus infusions over 10-15 seconds each).

Patients then undergo MRA immediately after each bolus infusion. Patients also undergo MRI at 4-6 hours, 16-20 hours, 24-28 hours, 48-52 hours, and 72 hours (if feasible) after receiving ferumoxytol.

After completion of study treatment, patients are followed for at least 1 month.

PROJECTED ACCRUAL: A total of 12 patients (6 per magnetic field strength for magnetic resonance angiography) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or radiologically confirmed diagnosis of 1 of the following:
- High-grade primary malignant brain tumor of 1 of the following subtypes:
  - High-grade glioma (WHO grade III or IV)
  - CNS lymphoma
- Brain metastases secondary to lung or breast cancer
No clinically significant signs of uncal herniation, including any of the following:
- Acute papillary enlargement
- Rapidly developing (over hours) motor change
- Rapidly decreasing level of consciousness

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Ferritin ≤ 1,000 ng/dL*
Transferrin ≤ 60%* NOTE: *Increased ferritin and transferrin levels allowed provided hemochromatosis is ruled out on hematology consultation

Hepatic

Bilirubin < 2 times upper limit of normal (ULN)
SGOT < 2 times ULN

Renal

Not specified

Other

Not pregnant or nursing
Fertile patients must use effective contraception during and for 1 month after study participation
No known allergic or hypersensitivity reaction to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations
- Patients with signficant allergy to drugs, other allergies, or autoimmune diseases may be eligible at the discretion of the principal investigator
No requirement for monitored anesthesia for MRI

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Prior chemotherapy for the primary brain tumor allowed

Endocrine therapy

Not specified

Radiotherapy

Prior radiotherapy for the primary brain tumor allowed

Surgery

Biopsy and/or surgery allowed only if clinically indicated

Other

Other prior therapy for the primary brain tumor allowed
Prior therapy for the primary lung or breast tumor allowed
No concurrent new over-the-counter drugs unless approved by the principal investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103038

Locations

United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098

Sponsors and Collaborators

OHSU Knight Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Edward A. Neuwelt, MD

OHSU Knight Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000413699, OHSU-813, NCI-6537, OHSU-8097
Study First Received:	February 7, 2005
Last Updated:	April 4, 2009
ClinicalTrials.gov Identifier:	NCT00103038 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult mixed glioma
primary central nervous system lymphoma
adult tumors metastatic to brain
recurrent breast cancer
stage IV breast cancer
recurrent non-small cell lung cancer
recurrent small cell lung cancer
stage IV non-small cell lung cancer
recurrent adult brain tumor

adult brain stem glioma
adult anaplastic astrocytoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma
adult glioblastoma
extensive stage small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Glioblastoma
Central Nervous System Lymphoma, Primary
Central Nervous System Neoplasms
Ependymoma
Respiratory Tract Diseases
Lung Neoplasms
Neoplasm Metastasis
Glioma
Lymphoma
Nervous System Neoplasms
Breast Diseases
Immunoproliferative Disorders

Astrocytoma
Skin Diseases
Breast Neoplasms
Recurrence
Carcinoma, Small Cell
Brain Neoplasms
Lymphatic Diseases
Lung Diseases
Non-small Cell Lung Cancer
Oligodendroglioma
Gliosarcoma
Lymphoproliferative Disorders
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Skin Diseases
Nervous System Diseases
Breast Neoplasms
Central Nervous System Neoplasms
Lymphatic Diseases
Neoplastic Processes

Neoplasms
Pathologic Processes
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Lymphoproliferative Disorders
Lymphoma
Nervous System Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009