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

Last updated: March 30, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer/tumors

Neurofibromatosis

Astrocytoma

Treatment

Neurocognitive Assessment

Quality-of-Life Assessment

Magnetic Resonance Imaging

Clinical Study ID

NCT04771806
PA17-0844
NCI-2020-08129
PA17-0844
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients with histologic confirmation of high grade glioma

  • Patients must be age >= 18 years

  • Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol, and has been approved and amended by the MD Anderson Cancer Center (MDACC) Institutional Review Board (IRB)

  • Patients must have Karnofsky performance status (KPS) >= 60

  • Patients must be able to obtain an MRI scan with gadolinium contrast

  • Female patients of childbearing age must not be pregnant as determined with a serum beta human chorionic gonadotropin (HCG) no greater than 14 days prior to study registration, or breastfeeding. (The exclusion is made because gadolinium may be teratogenic in pregnancy). Female patients who consent to participate in the study will need to use contraceptive methods for the duration of the study

Study Design

Total Participants: 80
Treatment Group(s): 4
Primary Treatment: Neurocognitive Assessment
Phase:
Study Start date:
April 01, 2019
Estimated Completion Date:
February 02, 2027

Study 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.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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