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Improved Characterization of Brain Tumors By MRI and MRS


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

Improved Characterization of Brain Tumors By MRI and MRS


OBJECTIVES:

- Determine the magnetic resonance spectroscopic imaging (MRSI) characteristics of
patients who are undergoing treatment for supratentorial glioma.

- Determine the survival of patients who undergo magnetic resonance imaging and MRSI.

- Determine the clinical outcome of patients who undergo these imaging procedures.

- Correlate measures of metabolic tumor burden (i.e., CNI, CCCrI, CrNI, and LLI) with
survival and clinical outcome in patients who undergo these imaging procedures.

- Determine the time to clinical progression in patients who undergo these imaging
procedures.

OUTLINE: Patients are assigned to 1 of 2 treatment groups based on grade of disease.

- Group 1 (patients with grade II glioma): Patients undergo magnetic resonance imaging
(MRI) and magnetic resonance spectroscopic imaging (MRSI). Patients then receive
chemotherapy. Patients undergo repeat MRI/MRSI after courses 2 and 4 of chemotherapy.

- Group 2 (patients with grade III-IV glioma): Patients undergo MRI/MRSI and then undergo
surgical resection of the tumor. Patients then receive chemoradiotherapy. Patients
undergo repeat MRI/MRSI within 2 weeks and at 2 months after completion of
radiotherapy.

Patients are followed for recurrence, disease progression, and survival.

PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed supratentorial glioma

- Grade II-IV disease

- Previously untreated disease

- Eligible for surgical resection and/or chemotherapy with or without radiotherapy

- Tumor accessible by magnetic resonance spectroscopic imaging

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

- Life expectancy ≥ 8 weeks

- Not pregnant

- No contraindication for magnetic resonance examinations, including any of the
following:

- Cardiac pacemaker or fibrillator

- Aneurysm clip

- Insulin or infusion pump

- Any implant held in place by a magnet

- Metal contamination anywhere in the body

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy

- No prior radiotherapy

- No prior treatment for the malignancy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Survival

Safety Issue:

No

Principal Investigator

Sarah J. Nelson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000441015

NCT ID:

NCT00274755

Start Date:

November 2003

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult anaplastic astrocytoma
  • adult diffuse astrocytoma
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult pilocytic astrocytoma
  • adult anaplastic ependymoma
  • adult ependymoma
  • adult myxopapillary ependymoma
  • adult subependymoma
  • adult anaplastic oligodendroglioma
  • adult oligodendroglioma
  • adult mixed glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115