Clinical trial NCT04771806: Serial Advanced Magnetic Resonance Imaging Scan for Guidance of Personalized Adaptive Radiotherapy for High Grade Glioma
Official title: Serial Advanced Magnetic Resonance Imaging (MRI) for Guidance of Personalized Adaptive Radiotherapy for High Grade Glioma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Glioma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologic confirmation of high grade glioma

Brief 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.

Eligibility 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

Primary outcomes:
measure: Differences in the delineated target and organ at risk volumes and dosimetry
timeFrame: Up to 2 years
measure: Cumulative dosimetric differences for the target volume and normal structures
timeFrame: Up to 2 years
Secondary outcomes:
measure: Incidence and temporal relationship of tumor progression between surgery and radiation therapy
timeFrame: Up to 2 years
measure: Local tumor control
timeFrame: At 6 months post-treatment
measure: Local tumor control
timeFrame: At 12 months post-treatment
measure: Overall survival (OS)
timeFrame: From the date of start of radiation to the date of death, assessed up to 2 years
measure: Changes in co-registration accuracy under the two settings
timeFrame: Baseline up to 2 years
measure: Difference in reported pseudoprogression
timeFrame: Up to 6 weeks after completion of radiation
measure: Dosimetric differences
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Caroline Chung
role: PRINCIPAL_INVESTIGATOR
References: