Menu
Recruiting NCT04771806

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

Observational Malignant Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Imaging, Neurocognitive Assessment, Quality-of-Life Assessment, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Malignant Glioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Magnetic Resonance Imaging
    Undergo MRI
  • Other Neurocognitive Assessment
    Undergo neurocognitive testing
  • Other Quality-of-Life Assessment
    Ancillary studies
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Differences in the delineated target and organ at risk volumes and dosimetry [Time frame: Up to 2 years]
  • Cumulative dosimetric differences for the target volume and normal structures [Time frame: Up to 2 years]
Secondary outcome measures (7)
  • Incidence and temporal relationship of tumor progression between surgery and radiation therapy [Time frame: Up to 2 years]
  • Local tumor control [Time frame: At 6 months post-treatment]
  • Local tumor control [Time frame: At 12 months post-treatment]
  • Overall survival (OS) [Time frame: From the date of start of radiation to the date of death, assessed up to 2 years]
  • Changes in co-registration accuracy under the two settings [Time frame: Baseline up to 2 years]
  • Difference in reported pseudoprogression [Time frame: Up to 6 weeks after completion of radiation]
  • Dosimetric differences [Time frame: Up to 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04771806 · PA17-0844 · NCI-2020-08129 · PA17-0844

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗