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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT02608619

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Erdheim-Chester Disease Langerhans Cell Histiocytosis Histiocytic Disorders	Radiation: F-choline PET Scan Device: FDG-PET Procedure: biopsy

Study Design

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 :

Nov 1, 2015

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

percentage of patients who successfully undergo paired biopsies [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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.