Using a Novel Functional MRI Technique to Evaluate for Neurotoxicity
NCT ID: NCT03342586
Last Updated: 2022-08-08
Study Results
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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COMPLETED
14 participants
OBSERVATIONAL
2017-11-07
2022-08-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Central Nervous System Lymphoma
Participants will have non-Hodgkins lymphoma involving the brain (primary or secondary)
Resting State fMRI (rsfMRI)
rsfMRI before receiving High-dose chemotherapy with autologous stem cell transplantation/HDC-ASCT (pre-HDC-ASCT), at approximately 3 months (+/- 2 weeks) after HDC-ASCT (early post-HDC-ASCT) and approximately 6months (+/- 2 weeks) after HDC-ASCT (late post-HDC-ASCT).
Auditory Attention and Executive Functions Test
* Trail Making Test (Parts A \& B): Part A is a timed test of visual scanning and graphomotor speed; AT: 3 minutes. Part B is a timed measure of set-shifting; Administration Time (AT): 5 minutes. Test-retest reliabilities=0.64-0.94.
* Brief Test of Attention-BTA assesses auditory working memory; AT: 10 minutes. Test-re-test reliability=0.70.
* Controlled Oral Word Association Test-COWAT is a timed measure of phonemic verbal fluency. It requires the subject to generate as many words as possible, beginning with a given letter of the alphabet (i.e., F, A, and S). The subject is allowed 60 seconds per letter, and the resultant score is the total number of words produced. Test-retest reliability=0.88. AT: 5 minutes.
Memory Test
The Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R is a test of verbal learning and memory.
Motor Speed Test
Grooved Pegboard Test (GPT)-Dominant Hand and Non-Dominant Hand. It is a timed test of manual dexterity, in which the time to completion is scored separately for each hand.
Self Reported Quality of Life Questionnaire
The Functional Assessment of Cancer Therapy-Brain Cancer (FACT-BR Version 4) consists of 46 questions with five domains assessing physical well-being, social/family well-being, emotional well-being, functional well being, additional concerns. The neuropsychological and QOL assessments will be performed by a neuropsychologist or by a trained RSA under the neuropsychologist's direct supervision.
Interventions
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Resting State fMRI (rsfMRI)
rsfMRI before receiving High-dose chemotherapy with autologous stem cell transplantation/HDC-ASCT (pre-HDC-ASCT), at approximately 3 months (+/- 2 weeks) after HDC-ASCT (early post-HDC-ASCT) and approximately 6months (+/- 2 weeks) after HDC-ASCT (late post-HDC-ASCT).
Auditory Attention and Executive Functions Test
* Trail Making Test (Parts A \& B): Part A is a timed test of visual scanning and graphomotor speed; AT: 3 minutes. Part B is a timed measure of set-shifting; Administration Time (AT): 5 minutes. Test-retest reliabilities=0.64-0.94.
* Brief Test of Attention-BTA assesses auditory working memory; AT: 10 minutes. Test-re-test reliability=0.70.
* Controlled Oral Word Association Test-COWAT is a timed measure of phonemic verbal fluency. It requires the subject to generate as many words as possible, beginning with a given letter of the alphabet (i.e., F, A, and S). The subject is allowed 60 seconds per letter, and the resultant score is the total number of words produced. Test-retest reliability=0.88. AT: 5 minutes.
Memory Test
The Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R is a test of verbal learning and memory.
Motor Speed Test
Grooved Pegboard Test (GPT)-Dominant Hand and Non-Dominant Hand. It is a timed test of manual dexterity, in which the time to completion is scored separately for each hand.
Self Reported Quality of Life Questionnaire
The Functional Assessment of Cancer Therapy-Brain Cancer (FACT-BR Version 4) consists of 46 questions with five domains assessing physical well-being, social/family well-being, emotional well-being, functional well being, additional concerns. The neuropsychological and QOL assessments will be performed by a neuropsychologist or by a trained RSA under the neuropsychologist's direct supervision.
Eligibility Criteria
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Inclusion Criteria
* Age 18-80 years
* Treatment plan for HDC-ASCT
* Fluent in English
* Patients who in the judgment of the investigators and/or consenting professional, are able to understand the purpose of the study and provide informed consent will be included.
Exclusion Criteria
* Any contraindication to the use of contrast and/or general guidelines for MR imaging as per standard Department of Radiology imaging guidelines
* Unable to cooperate for MRI
18 Years
80 Years
ALL
No
Sponsors
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Rutgers University
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Behroze Vachha, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Related Info
Other Identifiers
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17-403
Identifier Type: -
Identifier Source: org_study_id
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