Clinical trial NCT03127709: A Study of Memory, Thinking, and Brain Imaging in Adults With Histiocytosis
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Histiocytosis
Keywords: 17-199
histiocytosis
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will have a 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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: neurocognitive function
timeFrame: 1 year
measure: quality of life
timeFrame: 1 year
measure: comparing of grey matter volume
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Eli Diamond, MD
role: PRINCIPAL_INVESTIGATOR
References: