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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Patients with histologic confirmation of high grade glioma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Neurocognitive Assessment

    Other intervention

    Undergo neurocognitive testing

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Observational (MRI)4 interventions

Trial outcomes

Primary outcomes

1

Differences in the delineated target and organ at risk volumes and dosimetry

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
2

Cumulative dosimetric differences for the target volume and normal structures

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

Secondary outcomes

1

Incidence and temporal relationship of tumor progression between surgery and radiation therapy

Specifically, the rate of change in volume between surgery and radiation therapy (RT) will be measured and reported.

Time frame
Up to 2 years
2

Local tumor control

Local control is defined as stable disease, partial response or complete response using Response Assessment in Neuro-Oncology (RANO) criteria.

Time frame
At 6 months post-treatment
3

Local tumor control

Local control is defined as stable disease, partial response or complete response using RANO criteria.

Time frame
At 12 months post-treatment
4

Overall survival (OS)

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
From the date of start of radiation to the date of death, assessed up to 2 years

Other outcomes

Sponsors and contacts

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