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

NCT04771806 | Recruiting

• 2 other identifiers: PA17-0844NCI-2020-08129
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Glioma

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 2 years

• 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.

  Up to 2 years

Secondary Outcomes (7)

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

  Up to 2 years

• Local tumor control

  At 6 months post-treatment

• Local tumor control

  At 12 months post-treatment

• Overall survival (OS)

  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

  Baseline up to 2 years

Study Arms (1)

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; Other: Neurocognitive Assessment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Neurocognitive Assessment OTHER

Undergo neurocognitive testing

Observational (MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Observational (MRI)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Observational (MRI)

Questionnaire Administration OTHER

Ancillary studies

Observational (MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologic confirmation of high grade glioma

You may qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Glioma

Interventions

Magnetic Resonance Spectroscopy; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Caroline Chung

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Chung

CONTACT

713-563-2300; cchung3@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: February 25, 2021
• Study Start: April 1, 2019
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)