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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02608619
Enrollment
3
Registered
2015-11-20
Start date
2015-11-30
Completion date
2018-08-31
Last updated
2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erdheim-Chester Disease, Histiocytic Disorders, Langerhans Cell Histiocytosis

Keywords

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

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.

Interventions

RADIATIONF-choline PET Scan
DEVICEFDG-PET
PROCEDUREbiopsy

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
percentage of patients who successfully undergo paired biopsies1 yearThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026