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	Treatment or Intervention
Brain Tumor Breast Cancer Lung Cancer Lymphoma metastatic cancer	Drug: ferumoxytol  Procedure: diagnostic test  Procedure: magnetic resonance imaging

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Edward A. Neuwelt, MD,  Study Chair,  Oregon Health and Science University   

Study ID Numbers:  CDR0000413699; OHSU-8097; NCI-6537; NCT00103038
Record last reviewed:  January 2005
Last Updated:  February 15, 2005
Record first received:  February 7, 2005
ClinicalTrials.gov Identifier:  NCT00103038
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08