A prospective cohort study exploring the use of connectomics in tumour surgery

Not Applicable

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2022/11/046964
• Lead Sponsor: BrainSight Technology Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Glioma diagnosis

Eligible for surgical resection

Exclusion Criteria

Anyone <18 and >60 years of age

History of primary neurological disorders including seizure disorders/pre-existing disorders of development and degenerative disorders involving structural changes

Primary/pre-existing development and degenerative disorder involving structural changes

Primary/pre-existing Movement, Vision and speech disorders

Surgery in adjunct with cranial radiotherapy

Follow-up cases

Patients with contraindications to magnetic resonance imaging scanning

Pregnant women

Cases of meningioma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To compare the functional networks used for pre-surgical planning derived using VoxelBoxâ??s AI augmented rs-fMRI with that of tb-fMRI on the same patient <br/ ><br>2. To define a methodology for predicting the changes in functional brain networks due to the morphometric changes, with an emphasis on midline shift, in the tissue surrounding the tumor and correlating the same with the IDH mutation status. <br/ ><br>3. To define the utility of AI augmented functional connectomic approach (sMRI+DTI+ functional MRI) using rs-fMRI for surgical planning to the surgeon, radiologist and the patient in terms of economy, efficiency and effectiveness against tb-fMRI methods alone.Timepoint: These outcomes are planned to be achieved within 12 months.

Secondary Outcome Measures

Name	Time	Method
To compare Artificial Intelligence/ machine learning based methods that can automate the process of tumor demarcation and establish non-inferiority when compared to manual methods and MRS (where applicable). <br/ ><br>To test the feasibility of VoxelBox in addressing edge cases whose outcome could be improved using a multimodal functional connectomics approach.Timepoint: 12 months.