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

Langerhans Cell Histiocytosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608619
• Other study ID #: 15-268
• Status: Completed
• Start date: November 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Erdheim-Chester Disease
• Histiocytic Disorders
• Histiocytosis
• Histiocytosis, Langerhans-Cell
• Langerhans Cell Histiocytosis

Intervention

Radiation:
• F-choline PET Scan

Device:
• FDG-PET

Procedure:
• biopsy

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients who successfully undergo paired biopsies	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center