HistiocytosisNCT03127709
A Study of Memory, Thinking, and Brain Imaging in Adults With Histiocytosis
An observational study of Histiocytosis, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Histiocytosis
- What is being tested?
- Trail Making Test, Parts A & B, Brief Test of Attention and Symbol Span
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Apr 2017to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
About this study
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
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
- Being tested
- Trail Making Test, Parts A & B, Brief Test of Attention, Symbol Span, Controlled Oral Word Association Test, The Hopkins Verbal Learning Test-Revised
- Keywords
- 17-199, histiocytosis
- Medical subject headings
- Histiocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trail Making Test, Parts A & BBehavioural
Part A is a timed measure of visual scanning and graphomotor speed. Part B is a timed measure of cognitive flexibility.
Brief Test of AttentionBehavioural
Also called BTA
Assesses auditory working memory
Symbol SpanBehavioural
Also called WMS-IV
Assesses visual working memory
Controlled Oral Word Association TestBehavioural
Also called COWA
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-RevisedBehavioural
Also called HVLT-R
HVLT-R is a test of verbal learning and memory. Scores obtained are the total number of words.
Brief Visuospatial Memory Test-RevisedBehavioural
Also called BVMT-R
The BVMT-R is a test of visuospatial learning and memory.
Hospital Anxiety and Depression ScaleBehavioural
Also called HADS
The HADS is a brief assessment validated in many cancer populations.
McGill Quality of Life ScaleBehavioural
Also called McGill QOL
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 ImagingDiagnostic 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 MRIDiagnostic test
Also called rsFMRI
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Trail Making Test, Parts A & B; Behavioral: Brief Test of Attention; Behavioral: Symbol Span; Behavioral: Controlled Oral Word Association Test; Behavioral: The Hopkins Verbal Learning Test-Revised; Behavioral: Brief Visuospatial Memory Test-Revised; Behavioral: Hospital Anxiety and Depression Scale; Behavioral: McGill Quality of Life Scale; Diagnostic Test: MR Brain Imaging; Diagnostic Test: Resting state functional MRI; Behavioral: Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog) |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurocognitive function
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.
Measured: 1 year
quality of life
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.
Measured: 1 year
comparing of grey matter volume
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start7 Apr 2017
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HistiocytosisStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eli Diamond, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127709
- Sponsor's protocol ID
- 17-199
- Status last verified
- May 2026
- First submitted
- 11 Apr 2017
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03127709
- Acronym / sponsor ID
- 17-199
- Conditions
- Histiocytosis
- Keywords
- 17-199, histiocytosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with a histiocytic disorder diagnosis | – | Behavioral: Trail Making Test, Parts A & B, Behavioral: Brief Test of Attention, Behavioral: Symbol Span, Behavioral: Controlled Oral Word Association Test, Behavioral: The Hopkins Verbal Learning Test-Revised, Behavioral: Brief Visuospatial Memory Test-Revised, Behavioral: Hospital Anxiety and Depression Scale, Behavioral: McGill Quality of Life Scale, Diagnostic Test: MR Brain Imaging, Diagnostic Test: Resting state functional MRI, Behavioral: Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)Participants will have a histiocytic disorder as determined by a corroborating constellation of histopathology, clinical, and/or radiologic findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trail Making Test, Parts A & BPart A is a timed measure of visual scanning and graphomotor speed. Part B is a timed measure of cognitive flexibility. | Behavioural | Participants with a histiocytic disorder diagnosis |
| Brief Test of AttentionAlso: BTAAssesses auditory working memory | Behavioural | Participants with a histiocytic disorder diagnosis |
| Symbol SpanAlso: WMS-IVAssesses visual working memory | Behavioural | Participants with a histiocytic disorder diagnosis |
| Controlled Oral Word Association TestAlso: COWAThe 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). | Behavioural | Participants with a histiocytic disorder diagnosis |
| The Hopkins Verbal Learning Test-RevisedAlso: HVLT-RHVLT-R is a test of verbal learning and memory. Scores obtained are the total number of words. | Behavioural | Participants with a histiocytic disorder diagnosis |
| Brief Visuospatial Memory Test-RevisedAlso: BVMT-RThe BVMT-R is a test of visuospatial learning and memory. | Behavioural | Participants with a histiocytic disorder diagnosis |
| Hospital Anxiety and Depression ScaleAlso: HADSThe HADS is a brief assessment validated in many cancer populations. | Behavioural | Participants with a histiocytic disorder diagnosis |
| McGill Quality of Life ScaleAlso: McGill QOLThis is a questionnaire that is a validated 17-item QOL instrument validated for ill patients and in the particular context of the ancer. | Behavioural | Participants with a histiocytic disorder diagnosis |
| MR Brain ImagingStandard 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 | Participants with a histiocytic disorder diagnosis |
| Resting state functional MRIAlso: rsFMRIScanning 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. | Diagnostic test | Participants with a histiocytic disorder diagnosis |
| 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. | Behavioural | Participants with a histiocytic disorder diagnosis |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Memorial Sloan KetteringLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Histiocytosis
RecruitingPhase 2
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 2
Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders
Langerhan's Cell Histiocytosis, Juvenile Xanthogranuloma
Enrolling by invitationPhase 1/2
A Single-Arm,Multicenter Phase, Phase II Clinical Trial of Adebrelimab Combined With Trametinib in the Treatment of Refractory Recurrent Langerhans Cell Histiocytosis in Children and Adolescents
Histiocytosis,Langerhans-Cell
Active, not recruitingPhase 2
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eli Diamond, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Histiocytosis, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurocognitive function (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.