NCT06036394

Brief Summary

Radiotherapy involves the use of high-energy X-rays, which can be used to stop the growth of tumor cells. Radiotherapy constitutes an essential avenue in the treatment of brain tumors. The modern techniques of radiotherapy involve radiation planning techniques guided by computer algorithms aimed to deliver high doses of radiation to the areas of brain with tumors and limit the doses to surrounding normal structures. Artificial intelligence uses advanced analytical processes aided by computational analysis, which can be undertaken on the medical images, and radiation planning process. We plan to use artificial intelligence techniques to automatically delineate areas of the brain with tumor and other normal structures as identified from images. Also, we will use artificial intelligence on the radiation dose images and other images done for radiation treatment to classify tumors with good or bad prognoses, identify patients developing radiation complications, and detect responses after treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Sep 2023Sep 2028

First Submitted

Initial submission to the registry

August 28, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 13, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

5 years

First QC Date

August 28, 2023

Last Update Submit

April 8, 2025

Conditions

CNS Tumor

Keywords

Brain tumorGliomaRadiation OncologyArtificial IntelligenceMachine learning

Outcome Measures

Primary Outcomes (1)

  • Autosegmentation of organs at risk and target volumes.

    The agreement between manual segmentation and automated segmentation using an artificial intelligence-based model will be assessed using Dice coefficient of similarity.

    5 years

Secondary Outcomes (3)

  • Survival Analysis and Toxicity Estimation

    5 years

  • Dosiomic analysis

    5 years

  • Response assessment following treatment

    5 years

Other Outcomes (3)

  • Automated radiation planning and evaluation

    5 years

  • Data Banking

    5 years

  • Natural language processing for data interpretation

    5 years

Interventions

The images (CT, MRI, PET) used for RT planning, mid-treatment imaging as part of IGRT or disease evaluation, and response assessment/ surveillance post-RTDIAGNOSTIC_TEST

The radiation plans and dose-volume histogram will be obtained from TPS. All the images and radiation-related data will be downloaded from the PACS and TPS, applying anonymization filters. Clinical features (patient, disease, treatment-related characteristics, and outcomes) will be extracted by review of electronic medical records. Imaging pre-processing will be done, which will include skull stripping and registration across different modalities (e.g., MRI and CT) or different sequences(e.g., T1C, T2W, ADC) will be done using rigid or deformable algorithms as suited best for the modality

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

With approximately 500-600 patients with CNS tumors treated with RT in TMC every year, we expect a ceiling of 6000 patients during 2010-2022, which will be the maximum number of patients used for the analysis.

You may qualify if:

  • Patients with CNS tumors treated with radiation in TMC between January 2010 and December 2022.

You may not qualify if:

  • RT treatment outside TMC.
  • Radiation planning not done in the treatment planning system (treated using clinical marking/ conventional simulator).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioma

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Dr. ARCHYA DASGUPTA, MD

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr ARCHYA DASGUPTA, MD

CONTACT

91-22-24177000archya1010@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Radiation Oncology

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 13, 2023

Study Start

September 13, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations

IN(1)