Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study

Overview

The purpose of the study is to investigate the contribution of PET-CT with F18-choline in the diagnosis of thyroid nodule with indeterminate cytology in order to guide the best indication of surgical resection.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 28, 2019

Interventions

  • Device: Radiation : PET-CT with F18-choline examination
    • PET-CT with F18-choline examination will be performed before surgery

Arms, Groups and Cohorts

  • Experimental: PET-CT with F18-choline
    • PET-CT with F18-choline examination will be performed before surgery

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity
    • Time Frame: Up to 4 months
    • Sensitivity of 18F-choline PET to detect the cases of thyroid cancer among patients with thyroid nodule with an indeterminate cytology.
  • Specificity
    • Time Frame: Up to 4 months
    • Specificity of 18F-choline PET to detect the cases of thyroid cancer among patients with thyroid nodule with an indeterminate cytology.

Secondary Measures

  • Predictive diagnostic capabilities
    • Time Frame: Up to 4 months
    • Diagnostic capabilities of 18F-Choline PET in predicting thyroid cancer
  • Duration for acquisition
    • Time Frame: Up to 4 months
    • Determination of the optimal duration for the PET acquisition.

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 years – Patient with thyroid nodule ≥15 mm with an indeterminate cytology according to the Bethesda Classification 2008 (vesicular lesion of undetermined significance (Bethesda 3); follicular neoplasm or Hürthle cells (Bethesda 4); lesion suspicious for malignancy (Bethesda 5)), and to be operated on – Patient affiliated to a social security scheme – Informed consent and signed Exclusion Criteria:

  • Thyroid nodules <15 mm – Coalescing nodules preventing proper individualization of targeted nodule; – Thyroid nodule with non-diagnostic cytology (Bethesda 1), benign cytology (Bethesda 2) or malignant cytology (Bethesda 6) – Hot thyroid nodule on the thyroid scan – Major subject to a measure of legal protection or unable to consent – Pregnant women / nursing – Refusal to participate

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Francois Baclesse
  • Collaborator
    • Canceropôle Nord Ouest
  • Provider of Information About this Clinical Study
    • Sponsor

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