Validation of Edema-invariant Multi-shell High Angular Resolution Diffusion Imaging (msHARDI)-Based Tractography With Intra-operative Cortical Stimulation

NCT02559401 | Completed DMC

• 1 other identifier: UPCC 42313
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, standard-of-care tractography is based on information obtained from diffusion tensor imaging (DTI). DTI is a diffusion magnetic resonance imaging (dMRI) technique that is routinely obtained on neurosurgical patients to assist in pre-operative planning. The primary objective of the proposed study is to determine the ability of msHARDI-based tractography to discern fibers in edematous brain regions.

Conditions

Brain Lesions

Keywords

Eloquent cortex

Outcome Measures

Primary Outcomes (1)

• Number of subjects providing completion of the neurocognitive battery

  2 years

Interventions

MRI OTHER

Neurocognitive battery OTHER

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with brain lesions near eloquent cortex

You may qualify if:

• brain lesions, including but not limited to tumors, epileptic foci, and vascular abnormalities, in or around eloquent brain regions (i.e., motor, language);
• clinical need for pre-operative 'advanced imaging' (which includes conventional DTI);
• age between 18-80 years of age;
• male or female gender. Eloquent regions include: Temporal and frontal lobes (speech/language); bilateral occipital lobes (vision); bilateral parietal lobes (sensation); and bilateral motor cortex (movement).

You may not qualify if:

• a contraindication for obtaining an MRI scan (e.g. implanted devices, retrained foreign body)
• pregnancy
• absence of the capacity to make medical decisions or provide informed consent.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Steven Brem, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: September 24, 2015
• Study Start: June 1, 2014
• Primary Completion: October 1, 2020
• Study Completion: July 7, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

US (1)