Glioma Adaptive Radiotherapy With Development of an Artificial Intelligence Workflow

NCT06492486 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 4384
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diffuse Glioma; Glioblastoma; Adaptive Radiotherapy; Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

• Proportion of patients undergoing volumetric and biological adaptation. Cumulative rate of symptomatic radionecrosis (RN) at 2 years.

  Proportion of patients where modification of radiation plan was done.

  2 years

• Cumulative rate of symptomatic radionecrosis at 2 years

  Patients developing symptomatic radionecerosis will be analyzed using Kaplan-Meier survival method.

  4 years

Secondary Outcomes (2)

• Progression free survival

  4 years

• Overall survival

  4 years

Study Arms (2)

Stratum A (IDH-negative GBM)

EXPERIMENTAL

Adaptive radiotherapy

Radiation: Adaptive radiotherapy

Stratum B (IDH-mutant astrocytoma or oligodendroglioma)

EXPERIMENTAL

Adaptive radiotherapy

Radiation: Adaptive radiotherapy

Interventions

Adaptive radiotherapy RADIATION

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

Stratum A (IDH-negative GBM); Stratum B (IDH-mutant astrocytoma or oligodendroglioma)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of diffuse glioma. Patients with IDH-negative GBM (stratum A) and IDH-mutant glioma (astrocytoma or oligodendroglioma) need radiotherapy (stratum B).
• Age: 18-70 years. Karnofsky Performance Scale (KPS) ≥60

You may not qualify if:

• Multifocal or multicentric disease Not eligible for radical intent radiation. IDH status is unknown or uninterpretable (IHC or gene sequencing). Use of prior radiotherapy to the head-neck region or brain or chemotherapy. Contraindication/unable to undergo MRI or PET scan during radiation.

Sponsors & Collaborators

• Tata Memorial Centre: lead

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MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Archya Dasgupta

  Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Archya Dasgupta

CONTACT

2224177000; archya1010@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Radiation Oncology

Model Details: The proposed Phase II prospective study will be split into two strata: IDH-negative GBM (stratum A) and IDH-mutant glioma (astrocytoma or oligodendroglioma) needing radiotherapy (stratum B).

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 9, 2024
• Study Start: November 30, 2025
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share