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

NCT02608619 | Completed

• 1 other identifier: 15-268
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Erdheim-Chester Disease; Langerhans Cell Histiocytosis; Histiocytic Disorders

Keywords

18F-fluorocholine; Pet imaging; Biopsy; 15-268

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

F-choline PET Scan RADIATION

PET Imaging

FDG-PET DEVICE

PET Imaging

biopsy PROCEDURE

PET Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients for this study will be recruited by physicians from the Departments of Neurology.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memoral Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITHOUT DNA

tissue

MeSH Terms

Conditions

Erdheim-Chester Disease; Histiocytosis, Langerhans-Cell

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Eli Diamond, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

US (1)