GliomaAI-Astro4: MRI-Based Detection of IDH Mutant Astrocytoma Grade 4 (GliomaAI-A4)

June 23, 2026 updated by: Deep Learning Institute of Radiological Sciences

GliomaAI-Astro4: Non-Invasive MRI-Based Detection of IDH Mutant Astrocytoma Grade 4 Using Artificial Intelligence

The goal of this observational study is to learn whether an artificial intelligence system called GliomaAI-Astro4 can help detect a specific molecular type of brain tumour called IDH mutant Astrocytoma Grade 4 using routine MRI scans. The study uses previously collected and fully anonymised MRI data from 1,372 patients from 13 institutions in the Cancer Imaging Archive (TCIA).

The main questions it aims to answer are:

  • How accurately can GliomaAI-Astro4 identify IDH mutant Astrocytoma Grade 4 from MRI scans?
  • How well does the system perform across data from different hospitals and patient groups?

Researchers will use existing MRI scans and clinical information to train and test the AI system. No new scans, treatments, or hospital visits are required for participants, and all data used is fully anonymised and obtained from an existing research database.

Participants will not be asked to do anything, as this study only uses previously collected imaging data.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Mumbai, India
        • Deep Learning Institute of Radiological Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with glioma diagnosis included in the TCIA cohort.

Description

Inclusion Criteria:

  • Adult (>=18 years of age)
  • Having pre op MRI scan
  • Having biopsy / surgery
  • Having post biopsy/ surgery histology diagnosis and genetic analysis.

Exclusion Criteria:

  • MRI scan significantly degraded by motion or other artefact
  • Incomplete genetic analysis
  • Prior treatment (e.g., radiotherapy or chemotherapy) before baseline MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of GliomaAI-Astro4 for identification of IDH mutant astrocytoma grade 4 from MRI, measured by accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC.
Time Frame: Perioperative
The diagnostic performance of the GliomaAI-Astro4 artificial intelligence model will be assessed by comparing pre-operative MRI-based predictions of IDH mutant astrocytoma grade 4 status against post-operative (biopsy or surgery) molecular/genetic profiling results as the reference standard. Performance metrics including accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and AUC will be calculated.
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deep Learning Institute of Radiological Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2017

Primary Completion (Actual)

March 9, 2021

Study Completion (Actual)

June 16, 2021

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLIRS-GLIOMAAI-ASTRO4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol will be shared with researchers

IPD Sharing Time Frame

Study protocol and methodology will be published in an academic journal

IPD Sharing Access Criteria

We will strive to publish it in the open access academic journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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