Improving Surgical Outcomes in Patients With Low Grade Gliomas Using Advanced Pre- and Intra-operative MRI

NCT02884947 | Completed

• 2 other identifiers: 12/033612/LO/1977
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This aim of this study is to improve the outcomes for patient with gliomas undergoing neurosurgery by maximising the extent of resection whilst minimising neurological morbidity. This will be achieved through the use of advanced MRI, fMRI and DTI, performed at two stages of the patients' clinical management.

Conditions

Brain Neoplasms

Keywords

Brain Neoplasms; Magnetic Resonance Imaging; Neurosurgery

Outcome Measures

Primary Outcomes (3)

• Number of participants with clinically applicable intra-operatively acquired fMRI data.

  The intra-operatively acquired fMRI data will be assessed by a neuroradiologist, experienced in the interpretation of fMRI data for application to neurosurgical planning. The data will be evaluated using a 3 point scoring system.

  6 months following completion of data collection for 31 participants.

• Number of participants with spatially accurate co-registered pre-operative DTI data.

  The pre-operatively acquired DTI data, which has been co-registered using a non-rigid algorithm to intra-operatively acquired structural data, will be assessed for accuracy by comparison with intra-operatively acquired DTI using the Dice similarity coefficient (DSC).

  12 months following completion of data collection for 31 participants.

• Change in language fMRI data for participants

  The language fMRI data for participants will be compared with language fMRI data from a control group to assess for both group and individual differences. This will be performed using multivariate regression in the analysis program: Statistical Parametric Mapping.

  12 months following completion of data collection collection for 31 participants.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intrinsic brain tumours which require surgical resection

You may qualify if:

• Intrinsic brain tumour requiring resection
• Aged 18 years or over

You may not qualify if:

• Inability to give consent
• Contraindication to MRI
• No English language comprehension

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

UCL Institute of Neurology

London, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Prof Tarek Yousry, Dr. med. Habil, FRCR

  Neuroradiological Academic Unit, Department of Brain Repair and Rehabilitation, UCL Institute of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 31, 2016
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 9, 2018

Record last verified: 2016-08

Locations

GB (1)