NCT03127709

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Histiocytosis

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Brief Test of Attention	Assesses auditory working memory
BEHAVIORAL	Symbol Span	Assesses visual working memory
BEHAVIORAL	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).
BEHAVIORAL	The Hopkins Verbal Learning Test-Revised	HVLT-R is a test of verbal learning and memory. Scores obtained are the total number of words.
BEHAVIORAL	Brief Visuospatial Memory Test-Revised	The BVMT-R is a test of visuospatial learning and memory.
BEHAVIORAL	Hospital Anxiety and Depression Scale	The HADS is a brief assessment validated in many cancer populations.
BEHAVIORAL	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
BEHAVIORAL	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.

Timeline

• Start date: 2017-04-07
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2017-04-25
• Last updated: 2025-05-02

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study