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Clinical Trials/NCT02784223
NCT02784223
Completed
Not Applicable

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

Centre Francois Baclesse1 site in 1 country107 target enrollmentMay 2016
ConditionsThyroid Gland

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid Gland
Sponsor
Centre Francois Baclesse
Enrollment
107
Locations
1
Primary Endpoint
Sensitivity
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
March 28, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre Francois Baclesse
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Predictive diagnostic capabilities(Up to 4 months)
  • Duration for acquisition(Up to 4 months)

Study Sites (1)

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