NCT04771806

Serial Advanced Magnetic Resonance Imaging Scan for Guidance of Personalized Adaptive Radiotherapy for High Grade Glioma

Serial Advanced Magnetic Resonance Imaging (MRI) for Guidance of Personalized Adaptive Radiotherapy for High Grade Glioma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study examines whether repeated magnetic resonance imaging (MRI)s scan helps identify changes in the tumor during radiation and chemotherapy treatment in patients with high grade glioma. Additional MRIs scan may help researchers to see changes in the status of the disease. Seeing these changes may result in changes to the treatment plan.

Detailed description

PRIMARY OBJECTIVES: I. To compare the radiation dosimetric coverage of the surgical cavity and any residual tumor when the immediate post-operative MRI is used versus (vs.) newly acquired MRI prior to radiation therapy. II. To evaluate the cumulative dosimetric differences for the target volume and normal structures between an adaptive radiotherapy approach based on serial MRI vs. the conventionally delivered radiotherapy plan using the target and normal structure volumes from the initial MRI simulation. SECONDARY OBJECTIVES: I. To report the incidence of tumor progression between surgery and radiation therapy and factors related to higher risk of tumor progression (e.g. Time interval between surgery and radiation, extent of surgery, molecular characteristics). II. To evaluate the relationship between the delivered dosimetry and patterns of failure and changes in neurocognitive function. III. To evaluate the relationship between voxel-wise quantitative changes on multiparametric MRI including apparent diffusion coefficient (ADC), fractional anisotropy (FA), relative cerebral blood volume (rCBV), fractional volume of the extravascular, extracellular space (ve) and Ktrans (transfer constant that characterizes the diffusive transport of low-molecular weight gadolinium across the capillary endothelium) with patterns of failure and changes in neurocognitive function. IV. To determine if early post-operative progression is associated with worse overall survival. V. To determine the difference in reported pseudoprogression at first follow-up after completing radiation when the baseline MRI is the immediate post-op MRI vs. newly acquired MRI prior to radiation therapy. VI. To compare image co-registration accuracy between the radiation planning computed tomography (CT) images and MRI for the immediate post-op MRI vs. newly acquired MRI prior to radiation therapy. VII. To evaluate the relationship between standard clinical neurocognitive function (NCF) and iPad based NCF (iNCF) test results. OUTLINE: Patients undergo MRI with and without contrast immediately before radiotherapy (for radiation planning) and at mid treatment (week 3). Patients also undergo MRI without contrast on weeks 1, 2, 4, 5, and 6 of radiotherapy. Patients may also undergo neurocognitive function testing over 70 minutes before treatment, at the end of each week of treatment, and at 3 and 6 months after completion of treatment.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Neurocognitive Assessment	Undergo neurocognitive testing
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-04-01
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2021-02-25
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States