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

NCT ID: NCT02559401

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2022-07-07

Brief Summary

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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

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Conditions

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Brain Lesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MRI

Intervention Type OTHER

Neurocognitive battery

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Brem, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 42313

Identifier Type: -

Identifier Source: org_study_id

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