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

Brain Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559401
• Other study ID #: UPCC 42313
• Status: Completed
• Start date: June 2014
• Est. completion date: July 7, 2022

Study information

• Verified date: April 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 7, 2022
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Lesions

Intervention

Other:
• MRI

• Neurocognitive battery

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects providing completion of the neurocognitive battery		2 years