Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 15 for:    "Erdheim-Chester disease"

Uptake and Biodistribution of 18F-fluorocholine in Histiocytic Disorders by PET Imaging and Biopsy Measurement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608619
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The main purpose of this study is to discover how 18F-cholineFCH distributes in the body, and see if it can distinguish active histiocytes (tumor) from inflammatory (non- tumor) cells. This tracer has the potential to give the investigators' team more information when trying to identify the tumor cells that are most important to collect with biopsy. In addition, the study will measure levels of 18F-cholineFCH in the biopsy tissue.

Condition or disease Intervention/treatment
Erdheim-Chester Disease Langerhans Cell Histiocytosis Histiocytic Disorders Radiation: F-choline PET Scan Device: FDG-PET Procedure: biopsy

Layout table for study information
Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Determine Uptake and Biodistribution of 18F-fluorocholine in Histiocytic Disorders by PET Imaging and Biopsy Measurement
Actual Study Start Date : November 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018


Group/Cohort Intervention/treatment
PET Imaging
This study will enroll patients who have a clinical diagnosis of a systemic histiocytic disorder, and who are scheduled to undergo confirmatory biopsies of the systemic lesions, that were identified by standard imaging modalities.
Radiation: F-choline PET Scan
Device: FDG-PET
Procedure: biopsy



Primary Outcome Measures :
  1. percentage of patients who successfully undergo paired biopsies [ Time Frame: 1 year ]
    The overall histiocyte content will be described in each patient for each paired biopsy: there will be one biopsy that has high 18F-FCH F-choline uptake and one biopsy that has low 18F-FCH F-choline uptake.


Biospecimen Retention:   Samples Without DNA
tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients for this study will be recruited by physicians from the Departments of Neurology.
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • Suspected but pathologically unconfirmed diagnosis of Erdheim-Chester disease or Langerhans cell histiocytosis or other histiocytic disorder on the basis of clinical diagnosis, radiologic features, or findings from prior biopsies

Or

  • Confirmed diagnosis of Erdheim-Chester disease or Langerhans cell histiocytosis or other histiocytic disorder and requiring additional diagnostic imaging and biopsy to determine mutational status in order to determine therapeutic options.

Exclusion Criteria:

  • Inability to undergo or cooperate with PET/CT scan (e.g., claustrophobia)
  • Pregnant or nursing female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608619


Locations
Layout table for location information
United States, New York
Memoral Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Eli Diamond, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02608619     History of Changes
Other Study ID Numbers: 15-268
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Keywords provided by Memorial Sloan Kettering Cancer Center:
18F-fluorocholine
Pet imaging
Biopsy
15-268
Additional relevant MeSH terms:
Layout table for MeSH terms
Erdheim-Chester Disease
Histiocytosis, Langerhans-Cell
Histiocytosis
Disease
Pathologic Processes
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Histiocytosis, Non-Langerhans-Cell
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents