M D Anderson Cancer Center
Houston, Texas, 77030, United States
Location status: Recruiting
NCT Number: NCT04771806
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Houston, Texas, 77030, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Undergo MRI
Other names: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Undergo neurocognitive testing
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Time frame: Up to 2 years
Will be compared between the plans generated using the immediate post-op MRI versus (vs.) MR simulation. A Kolmogorov-Smirnov test will be used to assess distributional (histogram) changes between the two scenarios.
Time frame: Up to 2 years
Cumulative dosimetric differences for the target volume and normal structures between an adaptive radiotherapy approach based on serial MR images vs. the conventionally delivered radiotherapy plan. A Kolmogorov-Smirnov test will be used to assess distributional (histogram) changes between the two scenarios.
Time frame: Up to 2 years
Specifically, the rate of change in volume between surgery and radiation therapy (RT) will be measured and reported.
Time frame: At 6 months post-treatment
Local control is defined as stable disease, partial response or complete response using Response Assessment in Neuro-Oncology (RANO) criteria.
Time frame: At 12 months post-treatment
Local control is defined as stable disease, partial response or complete response using RANO criteria.
Time frame: From the date of start of radiation to the date of death, assessed up to 2 years
A Cox proportional hazards regression model will be constructed to associate post-op progression with OS, after adjusting for age, IDH mutation, Karnofsky performance status and extent-of-resection.
Time frame: Baseline up to 2 years
A paired t-test (or a nonparametric analog) will be used to assess changes in co-registration accuracy under the two settings (post-op MRI vs. newly acquired MRI prior to radiation therapy).
Time frame: Up to 6 weeks after completion of radiation
Will determine the difference in the reported incidence of pseudoprogression at first follow-up after completion of 6 weeks of radiation when the immediate post-resection MRI is used as the baseline vs. newly acquired MRI prior to radiation therapy as the baseline. A binomial test of proportions between reported pseudo-progression in postsurgical MRI vs. baseline pre-radiation MRI with contrast will be performed.
Time frame: Up to 2 years
Will be assessed via paired t-test (or a nonparametric analog).
Contact information is provided by the study sponsor or research team.
M.D. Anderson Cancer Center
Other
Serial Advanced Magnetic Resonance Imaging (MRI) for Guidance of Personalized Adaptive Radiotherapy for High Grade Glioma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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