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

Purpose

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.

Condition

  • Malignant Glioma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Observational (MRI) 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.
  • Procedure: Magnetic Resonance Imaging
    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
  • Other: Neurocognitive Assessment
    Undergo neurocognitive testing
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Caroline Chung
713-563-2300

More Details

Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

Caroline Chung
713-563-2300
cchung3@mdanderson.org

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.