A Study of Memory, Thinking, and Brain Imaging in Adults With Histiocytosis
NCT ID: NCT03127709
Last Updated: 2025-05-02
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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ACTIVE_NOT_RECRUITING
13 participants
OBSERVATIONAL
2017-04-07
2026-04-30
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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Participants with a histiocytic disorder diagnosis
Participants will have a histiocytic disorder as determined by a corroborating constellation of histopathology, clinical, and/or radiologic findings.
Trail Making Test, Parts A & B
Part A is a timed measure of visual scanning and graphomotor speed. Part B is a timed measure of cognitive flexibility.
Brief Test of Attention
Assesses auditory working memory
Symbol Span
Assesses visual working memory
Controlled Oral Word Association Test
The COWA timed test 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 Hopkins Verbal Learning Test-Revised
HVLT-R is a test of verbal learning and memory. Scores obtained are the total number of words.
Brief Visuospatial Memory Test-Revised
The BVMT-R is a test of visuospatial learning and memory.
Hospital Anxiety and Depression Scale
The HADS is a brief assessment validated in many cancer populations.
McGill Quality of Life Scale
This is a questionnaire that is a validated 17-item QOL instrument validated for ill patients and in the particular context of the ancer.
MR Brain Imaging
Standard of care brain MR imaging includes high-resolution 3D T1-weighted images in the axial plane. The axial T1-weighted images will be isotropic with a typical matrix size of 256 x 256, 256 mm field-of-view (FOV) and 1 mm slice thickness covering the whole brain.
Resting state functional MRI
Scanning will be performed on a 3 Tesla General Electric scanner (Optima 750W) with a GEM HNU 24-channel head coil. rsFMRI matching the FLAIR and T1 post-contrast images will be obtained. For resting state fMRI, T2\*-weighted images will be acquired with a single-shot gradient echo echo-planar imaging (EPI) sequence in the axial orientation (TR = 2500 ms, TE = 30 ms, FA = 80°, slice thickness = 4 mm, FOV= 240mm2, matrix=64×64) covering whole brain. For the resting state fMRI portion of the scan, patients will be instructed by the technologist or research staff to leave eyes open, focus on looking at a crosshair, and not think about anything during the scan.
Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
This is a validated 37-item QOL instrument for cancer patients with cognitive complaints. The measures consist of FACT-Cog total, perceived cognitive impairments, perceived cognitive abilities, and impact on quality of life.
Interventions
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Trail Making Test, Parts A & B
Part A is a timed measure of visual scanning and graphomotor speed. Part B is a timed measure of cognitive flexibility.
Brief Test of Attention
Assesses auditory working memory
Symbol Span
Assesses visual working memory
Controlled Oral Word Association Test
The COWA timed test 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 Hopkins Verbal Learning Test-Revised
HVLT-R is a test of verbal learning and memory. Scores obtained are the total number of words.
Brief Visuospatial Memory Test-Revised
The BVMT-R is a test of visuospatial learning and memory.
Hospital Anxiety and Depression Scale
The HADS is a brief assessment validated in many cancer populations.
McGill Quality of Life Scale
This is a questionnaire that is a validated 17-item QOL instrument validated for ill patients and in the particular context of the ancer.
MR Brain Imaging
Standard of care brain MR imaging includes high-resolution 3D T1-weighted images in the axial plane. The axial T1-weighted images will be isotropic with a typical matrix size of 256 x 256, 256 mm field-of-view (FOV) and 1 mm slice thickness covering the whole brain.
Resting state functional MRI
Scanning will be performed on a 3 Tesla General Electric scanner (Optima 750W) with a GEM HNU 24-channel head coil. rsFMRI matching the FLAIR and T1 post-contrast images will be obtained. For resting state fMRI, T2\*-weighted images will be acquired with a single-shot gradient echo echo-planar imaging (EPI) sequence in the axial orientation (TR = 2500 ms, TE = 30 ms, FA = 80°, slice thickness = 4 mm, FOV= 240mm2, matrix=64×64) covering whole brain. For the resting state fMRI portion of the scan, patients will be instructed by the technologist or research staff to leave eyes open, focus on looking at a crosshair, and not think about anything during the scan.
Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
This is a validated 37-item QOL instrument for cancer patients with cognitive complaints. The measures consist of FACT-Cog total, perceived cognitive impairments, perceived cognitive abilities, and impact on quality of life.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fluency in English
* Diagnosis of a histiocytic disorder as determined, in the opinion of the study PI, by a corroborating constellation of histopathology, clinical, and/or radiologic findings.
* Will undergo Standard of Care MRI.
Exclusion Criteria
* Prior stroke or intracranial hemorrhage
* Other (non-histiocytic) intracranial neoplasm or neurological disorder deemed by the PI or Co-PI to confound neuroimaging studies (e.g., demyelinating disease)
* Existing diagnosis of a psychiatric disorder or untreated mood disturbance
* Existing diagnosis of a neurodegenerative disease, such as Alzheimer's disease
* Chronic or daily excessive alcohol consumption as determined by the PI.
* History of chronic use of corticosteroids, defined as continuous treatment for six months or longer at any time in the past
* History of severe claustrophobia or other contraindications to patient SOC brain MRI
* Prior intravenous cytarabine or cladribine
* Other current or prior treatments (e.g., high-dose chemotherapy for a different cancer) deemed by the PI or Co-PI to confound imaging studies or cognitive performance
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Eli Diamond, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering
Other Identifiers
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17-199
Identifier Type: -
Identifier Source: org_study_id
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