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NCT Number: NCT03127709

A Study of Memory, Thinking, and Brain Imaging in Adults With Histiocytosis

The purpose of this study is to try to understand how histopcytosis can cause symptoms or problems in the brain. The tests being done in the study will look at memory and thinking as well as brain function via MRI scan.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Histiocytosis Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than or equal to 18 years.
  • 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

  • Known intracranial involvement of histiocytosis (including dura, leptomeninges and brain parenchyma)
  • 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

Treatment and study plan

Trail Making Test, Parts A & B

Behavioral

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

Behavioral

Assesses auditory working memory

Other names: BTA

Symbol Span

Behavioral

Assesses visual working memory

Other names: WMS-IV

Controlled Oral Word Association Test

Behavioral

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).

Other names: COWA

The Hopkins Verbal Learning Test-Revised

Behavioral

HVLT-R is a test of verbal learning and memory. Scores obtained are the total number of words.

Other names: HVLT-R

Brief Visuospatial Memory Test-Revised

Behavioral

The BVMT-R is a test of visuospatial learning and memory.

Other names: BVMT-R

Hospital Anxiety and Depression Scale

Behavioral

The HADS is a brief assessment validated in many cancer populations.

Other names: HADS

McGill Quality of Life Scale

Behavioral

This is a questionnaire that is a validated 17-item QOL instrument validated for ill patients and in the particular context of the ancer.

Other names: McGill QOL

MR Brain Imaging

Diagnostic Test

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

Diagnostic Test

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.

Other names: rsFMRI

Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)

Behavioral

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.

Primary outcomes

  1. neurocognitive function

    Time frame: 1 year

    Neurocognitive tests will yield raw scores that are converted to z-scores, normalized for participant's age, sex and educational level.The proportion of participants demonstrating cognitive impairment (as defined by 2 or more z-scores less than -1.5) will be summarized. Also, the proportion of participants with impairment (z < -1.5) for each cognitive test will be summarized. In this way the cognitive assessment yields a dichotomous outcome of impaired versus not impaired for each participant but also allow for more granular assessment of impairment in specific cognitive domains.

  2. quality of life

    Time frame: 1 year

    questionnaires will yield raw scores (total score for HADS and McGill QOL, as well as anxiety and depression subscores for the HADS). QOL scores will be analyzed as raw scores. Cognitive test scores will be transformed into z-sores (based on score distributions from established normative samples with a mean of 0 and standard deviation of 1) to define the presence/severity of cognitive dysfunction. Scores will be normalized for age, sex and education.

  3. comparing of grey matter volume

    Time frame: 1 year

    In a whole-brain analysis, first, cortical thickness will be compared between participants and controls and regions of statistically significant grey matter loss will be identified. This is done computionally with a whole-brain, vertex-by-vertex approach, as stated above. Also, as stated above (Section 7), statistical significance thresholding is at p<0.001, correcting for multiple comparisons using the False Discovery Rate (FDR) method and clustering thresholds, methods used in various high-throughput contexts, including MRI analysis.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Clinical, Structural, and Functional Neuroimaging Study of Cognition in Adults With Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman Disease, and Other Histiocytoses

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2017
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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