NCT03137888

Spectroscopic MRI-Guided Radiation Therapy Planning in Glioblastoma

Pilot Study of Spectroscopic MRI-Guided, Dose-Escalated Radiation Therapy for Newly-Diagnosed Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies the side effects of spectroscopic magnetic resonance imaging (MRI)-guided radiation therapy and how well it works in treating patients with newly-diagnosed glioblastoma or gliosarcoma. Spectroscopic MRI can show doctors where the extent of tumor is in the brain beyond current clinical MRI scans by mapping areas of high tumor metabolism. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Spectroscopic MRI-guided radiation therapy may work better in treating patients with glioblastoma or gliosarcoma.

Detailed description

PRIMARY OBJECTIVES: I. To determine the feasibility of using spectroscopic MRI (sMRI) to guide dose-escalated radiation therapy (RT) for newly-diagnosed glioblastoma (GBM)s. II. To determine the safety of using sMRI to guide dose-escalated RT for newly-diagnosed GBMs. SECONDARY OBJECTIVE: I. To determine whether the progression free survival at 1 year with sMRI-guided, dose-escalated RT is improved for newly-diagnosed GBMs. TERTIARY OBJECTIVES: I. To determine whether sMRI-guided, dose-escalated RT increases the overall survival of patients with newly diagnosed GBMs. II. To determine whether sMRI data obtained after initiation of therapy (at 2 weeks after RT/TMZ start and prior to cycle 1 and 5 of adjuvant temozolomide \[TMZ\]) will provide early evidence of GBM progression not seen on standard MRIs. III. To determine whether performance on neurocognitive and quality-of-life (QOL) assessments in newly-diagnosed GBM patients treated with sMRI-guided, dose-escalated RT differ from historical controls. OUTLINE: Patients undergo sMRI-guided radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide orally (PO) daily during radiation therapy for up to 42 days. After completion of study treatment, patients are followed up every 3 months for up to 2 years and then periodically.

Conditions

• Glioblastoma
• Gliosarcoma

Interventions

Type	Name	Description
RADIATION	Dose-Escalated Radiation Therapy	Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
PROCEDURE	Spectroscopic Magnetic Resonance Imaging	Patients will undergo sMRI scans within a 14 day window prior to starting treatment
DRUG	Temozolomide	Given PO

Timeline

• Start date: 2017-09-20
• Primary completion: 2024-09-09
• Completion: 2024-09-09
• First posted: 2017-05-03
• Last updated: 2025-08-03
• Results posted: 2025-08-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study