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NCT00005084 Clinical Trial

Magnetic Resonance Imaging in Treating Children With Progressive Low-Grade Astrocytoma

Brain and Central Nervous System Tumors Clinical Trial

Official title:
Pediatric Low Grade Astrocytoma: Treatment Guidance

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00005084
Other study ID # CDR0000067693
Secondary ID UCLA-9702077NCI-
Status Active, not recruiting
Phase Phase 2
First received April 6, 2000
Last updated December 17, 2013
Start date February 1999

Study information
Verified date February 2008
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: New imaging procedures such as magnetic resonance imaging may improve the ability to determine the growth rate of progressive astrocytoma.

PURPOSE: Phase II trial to study the effectiveness of magnetic resonance imaging in treating children who have progressive low-grade astrocytoma.

Description:

OBJECTIVES: I. Determine if tumor growth rate can be decreased by targeting areas of increased choline activity, as measured by magnetic resonance spectroscopic imaging, in pediatric patients with progressive low grade astrocytoma treated with surgical resection and/or focal radiotherapy. II. Improve the quality of life without use of aggressive surgery or radiotherapy in this patient population.

OUTLINE: Patients undergo magnetic resonance spectroscopic imaging (MRSI) over 60 minutes prior to surgery and/or radiotherapy. Patients are assigned to one of two treatment arms based on tumor accessibility and may crossover to either arm. Arm I: Patients undergo conventional surgery. Arm II: Patients with inaccessible tumors undergo focal radiotherapy. Following surgery and/or radiotherapy, patients are followed every 4 months for up to 2 years with MRSI or MRI for tumor response and growth.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study over 2 years.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 24
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Years
Eligibility DISEASE CHARACTERISTICS: Diagnosis of low grade astrocytoma in the hypothalamus, brain stem, or thalamus of 5 cm on T2 weighted scans Incomplete surgical resection Previously treated with evidence of tumor progression No hemispheric or cerebellar masses

PATIENT CHARACTERISTICS: Age: 12 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• conventional surgery

• magnetic resonance spectroscopic imaging

Radiation:
• radiation therapy

Locations
Country Name City State
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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