Validation of Edema-invariant Multi-shell High Angular Resolution Diffusion Imaging (msHARDI)-Based Tractography With Intra-operative Cortical Stimulation
Completed
- Conditions
- Brain Lesions
- Registration Number
- NCT02559401
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of subjects providing completion of the neurocognitive battery 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States