Glioma Adaptive Radiotherapy With Development of an Artificial Intelligence Workflow

Sponsor
Tata Memorial Centre
Study ID
NCT06492486
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adaptive Radiotherapy
  • Artificial Intelligence
  • Diffuse Glioma
  • Glioblastoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Adaptive radiotherapy — RADIATION
    Volumetric and biological adaptive radiotherapy will be delivered based on interval imaging with MRI and PET scan during treatment.

Study Details

Gliomas are common primary brain tumors in adults. Gliomas can be classified into different types based on tumor grade, histopathological features, and molecular characteristics. The common types of diffuse gliomas include glioblastoma, astrocytoma, and oligodendroglioma. The standard treatment for diffuse gliomas includes surgery followed by radiation and chemotherapy. As per standard institutional practice, a uniform dose of radiation is delivered to the disease area and MRI is done before and after the treatment. In this study, MRI and PET scan will be done before starting the treatment and standard dose of radiation will be delivered. The interval imaging will be done twice during the course of treatment with MRI and PET, followed by dose modifications. The CT, MRI, and PET will be combined. Based on PET imaging, specific dose will be altered and delivered to specific areas. Dose modification will be done with the help of artificial intelligence. Participant's assessment will be done at regular intervals. Modifications in radiation plans are done based on the changes in disease seen in scans is likely to improve the accuracy of RT treatments. Dose modifications based on imaging to resistant areas will help achieve better tumor control, reduce treatment-related toxicities, precise delivery of the RT and adjusting doses to the organs at risk (OAR) and changes in disease leading to better treatment compliance. Creating an artificial intelligence framework in radiation oncology promises to improve quality of workflow, treatment planning and RT delivery. The aim of the study is to develop an artificial intelligence workflow for treatment of glioma with adaptive radiotherapy. This study will be conducted in Tata Memorial Centre on a population of 60 patients for a duration of 2 years. The total study duration is 4 years.

Key Dates

First listed
Jul 9, 2024
Start date
Jul 27, 2026
Status verified
Aug 2026
Primary completion
Jul 30, 2028
Completion
Jul 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum A (IDH-negative GBM)
    Adaptive radiotherapy
  • Experimental: Stratum B (IDH-mutant astrocytoma or oligodendroglioma)
    Adaptive radiotherapy

Primary Outcome Measure

Proportion of patients undergoing volumetric and biological adaptation. Cumulative rate of symptomatic radionecrosis (RN) at 2 years. [ Time Frame: 2 years ]

Central Contacts

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