Rationale: Diagnostic procedures, such as magnetic resonance imaging (MRI) using ferumoxytol, may help find and diagnose primary brain cancer or brain metastases.Purpose: This randomised clinical trial is studying how well MRI using ferumoxytol works in finding out the extent of the tumour in patients with primary brain cancer or brain metastases from lung or breast cancer.

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.

Conditions

  • Brain and Central Nervous System Tumours
  • Breast Cancer
  • Lung Cancer
  • Lymphoma

Study Type

Interventional

Study Design

Diagnostic

Further Details

Primary Outcomes:

  • Determine, preliminarily, the safety and efficacy of magnetic resonance imaging (MRI) using ferumoxytol in patients with primary malignant brain tumours 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 Outcomes:

  • Compare, preliminarily, ferumoxytol magnetic resonance angiography (MRA) with gadolinium MRA in these patients.
  • Determine, preliminarily, the number and size of tumours imaged in these patients.
  • Determine, preliminarily, tumour 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).

This is a randomised, pilot study. Patients are randomised 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.

Study Start

April 2004

Eligibility & Criteria

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

Disease Characteristics:

Histologically or radiologically confirmed diagnosis of 1 of the following:

  • High-grade primary malignant brain tumour 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:
              o Acute papillary enlargement
              o Rapidly developing (over hours) motor change
              o 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 anaesthesia for MRI

Prior Concurrent Therapy

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior chemotherapy for the primary brain tumour allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior radiotherapy for the primary brain tumour allowed

Surgery:

  • Biopsy and/or surgery allowed only if clinically indicated

Other:

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

Total Enrolment

Contact Details

Edward A. Neuwelt (MD)
Oregon Health and Science University Cancer Institute 

Location: 

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