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

Not Applicable

Completed

• Conditions: Thyroid Gland

• Registration Number: NCT02784223
• Lead Sponsor: Centre Francois Baclesse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-05-27
• Status Verified: 2019-03
• Primary Completion: 2019-03-28
• Study Completion: 2019-03-28
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Centre François Baclesse; 🇫🇷 Caen, France