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Trial record 7 of 10 for:
"Lipogranulomatosis"
Uptake and Biodistribution of 18F-fluorocholine in Histiocytic Disorders by PET Imaging and Biopsy Measurement
This study is currently recruiting participants.
Verified August 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02608619
First received: November 17, 2015
Last updated: August 18, 2016
Last verified: August 2016
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Purpose
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 | Intervention |
|---|---|
| Erdheim-Chester Disease Langerhans Cell Histiocytosis Histiocytic Disorders | Radiation: F-choline PET Scan Device: FDG-PET Procedure: biopsy |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Langerhans Cell Histiocytosis
Lipogranulomatosis
Erdheim-Chester Disease
U.S. FDA Resources
Further study details as provided by Memorial Sloan Kettering Cancer Center:
Primary Outcome Measures:
- 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
| Estimated Enrollment: | 5 |
| Study Start Date: | November 2015 |
| Estimated Primary Completion Date: | November 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02608619
Please refer to this study by its ClinicalTrials.gov identifier: NCT02608619
Contacts
| Contact: Eli Diamond, MD | 212-610-0243 | ||
| Contact: Ronald Blasberg, MD | 646-888-2211 |
Locations
| United States, New York | |
| Memoral Sloan Kettering Cancer Center | Recruiting |
| New YorK, New York, United States, 10065 | |
| Contact: Eli Diamond, MD 212-639-7576 | |
| Contact: Ronald Blasberg, MD 646-888-2211 | |
| Principal Investigator: Eli Diamond, MD | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
| Principal Investigator: | Eli Diamond, MD | Memorial Sloan Kettering Cancer Center |
More Information
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT02608619 History of Changes |
| Other Study ID Numbers: |
15-268 |
| Study First Received: | November 17, 2015 |
| Last Updated: | August 18, 2016 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
|
18F-fluorocholine Pet imaging Biopsy 15-268 |
Additional relevant MeSH terms:
|
Erdheim-Chester Disease Disease Histiocytosis Histiocytosis, Langerhans-Cell 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 |
ClinicalTrials.gov processed this record on July 14, 2017