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

Study Overview
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Brief Summary
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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.

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

Conditions
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Thyroid Gland

Intervention / Treatment
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* Device: Radiation : PET-CT with F18-choline examination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET-CT with F18-choline<br>PET-CT with F18-choline examination will be performed before surgery | Device: Radiation : PET-CT with F18-choline examination<br>* PET-CT with F18-choline examination will be performed before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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F18-choline, Surgery, Indeterminate, Thyroid node