Recruiting

Personalized Adaptive Radiotherapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04771806

Conditions

Malignant Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Imaging

Neurocognitive Assessment

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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

Study ID

NCT04771806

Start date

Apr 1, 2019

Status verified date

Mar, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Magnetic Resonance Imaging

Undergo MRI

Neurocognitive Assessment

Undergo neurocognitive testing

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Caroline Chung

713-563-2300cchung3@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Caroline Chung

713-563-2300

Principal Investigator:

Caroline Chung

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-04.