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

Malignant Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04771806
• Other study ID #: PA17-0844
• Secondary ID: NCI-2020-08129PA
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: February 2, 2027

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Caroline Chung
• Phone: 713-563-2300
• Email: cchung3[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma

Intervention

Procedure:
• Magnetic Resonance Imaging
Undergo MRI

Other:
• Neurocognitive Assessment
Undergo neurocognitive testing
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Up to 2 years
Secondary	Local tumor control	Local control is defined as stable disease, partial response or complete response using Response Assessment in Neuro-Oncology (RANO) criteria.	At 6 months post-treatment
Secondary	Local tumor control	Local control is defined as stable disease, partial response or complete response using RANO criteria.	At 12 months post-treatment
Secondary	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.	From the date of start of radiation to the date of death, assessed up to 2 years
Secondary	Changes in co-registration accuracy under the two settings	A paired t-test (or a nonparametric analog) will be used to assess changes in co-registration accuracy under the two settings (post-op MRI vs. newly acquired MRI prior to radiation therapy).	Baseline up to 2 years
Secondary	Difference in reported pseudoprogression	Will determine the difference in the reported incidence of pseudoprogression at first follow-up after completion of 6 weeks of radiation when the immediate post-resection MRI is used as the baseline vs. newly acquired MRI prior to radiation therapy as the baseline. A binomial test of proportions between reported pseudo-progression in postsurgical MRI vs. baseline pre-radiation MRI with contrast will be performed.	Up to 6 weeks after completion of radiation
Secondary	Dosimetric differences	Will be assessed via paired t-test (or a nonparametric analog).	Up to 2 years

External Links

•   MD Anderson Cancer Center Website