Brain LesionsNCT02559401
Validation of Edema-invariant Multi-shell High Angular Resolution Diffusion Imaging (msHARDI)-Based Tractography With Intra-operative Cortical Stimulation
An observational study of Brain Lesions, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Lesions
- What is being tested?
- MRI and Neurocognitive battery
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 7 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with brain lesions near eloquent cortex
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
- Being tested
- MRI, Neurocognitive battery
- Keywords
- Eloquent cortex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Neurocognitive batteryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects providing completion of the neurocognitive battery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startJun 2014
- Primary completion1 Oct 2020
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Brem, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559401
- Sponsor's protocol ID
- UPCC 42313
- Status last verified
- Apr 2023
- First submitted
- 19 Jun 2015
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Edema-invariant Multi-shell High Angular Resolution Diffusion Imaging (msHARDI)-Based Tractography With Intra-operative Cortical Stimulation
- ClinicalTrials.gov ID
- NCT02559401
- Acronym / sponsor ID
- UPCC 42313
- Conditions
- Brain Lesions
- Keywords
- Eloquent cortex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with brain lesions near eloquent cortex
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI | Other | – |
| Neurocognitive battery | Other | – |
Primary outcome
Number of subjects providing completion of the neurocognitive battery
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Brem, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Lesions, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects providing completion of the neurocognitive battery (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.