Diagnostic value of 18F-choline PET in patients with indeterminate cytology thyroid nodule : A pilot study

Conditions

Patient with a thyroid nodule =15mm with indefinite cytology according to the 2008 Bethesda classification (vesicular lesion of undetermined significance

Renaud Ciappuccini, Virginie Saguet-Rysanek, Marine Dorbeau, Justine Lequesne, Camille Linard et al. (8 authors)

European Thyroid Journal2022-05-185 citations

10.1530/etj-22-0025

<sup>18</sup> F-Fluorocholine Positron Emission Tomography/Computed Tomography is a Highly Sensitive but Poorly Specific Tool for Identifying Malignancy in Thyroid Nodules with Indeterminate Cytology: The Chocolate Study

Renaud Ciappuccini, Idlir Licaj, Audrey Lasne‐Cardon, E. Babin, Dominique de Raucourt et al. (13 authors)

Thyroid2020-11-1317 citations

10.1089/thy.2020.0555

Interventions

Trade Name: IASOcholine Product Name: Flurocholine (18F) Pharmaceutical Form: Radiopharmaceutical precursor, solution INN or Proposed INN: IASOcholine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient with a thyroid nodule = 15mm with indefinite cytology according to the 2008 Bethesda classification (vesicular lesion of undetermined significance; follicular neoplasm or cell Hürthle; lesion suspicious for malignancy), and to be operated - Age = 18 years - Patient affiliated to a social security scheme - Informed consent and signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 135

Exclusion criteria

Exclusion criteria: - Thyroid nodule <15mm - Coalescing nodules preventing a correct individualization of the target nodule; - Nodules with no indeterminate cytology , ie nondiagnostic cytology, benign and malignant cytology - Major subject of a legal protection measure or unable to consent - Refusal to participate

Design outcomes

Primary

Measure	Time frame
Main Objective: Establish the sensitivity of PET with 18F-choline to detect, among the patients with thyroid nodule with indeterminate cytology in the cases of thyroid cancer, taking as reference the histology of the nodule (WHO 2004 classification) after surgery.;Secondary Objective: Estimate the diagnostic capabilities of PET with 18F-Choline in predicting thyroid cancers, as well as the optimal time required for the acquisition of the PET image centered on the cervical region .;Primary end point(s): Sensitivity;Timepoint(s) of evaluation of this end point: After surgery	—

Measure

Time frame

Main Objective: Establish the sensitivity of PET with 18F-choline to detect, among the patients with thyroid nodule with indeterminate cytology in the cases of thyroid cancer, taking as reference the histology of the nodule (WHO 2004 classification) after surgery.;Secondary Objective: Estimate the diagnostic capabilities of PET with 18F-Choline in predicting thyroid cancers, as well as the optimal time required for the acquisition of the PET image centered on the cervical region .;Primary end point(s): Sensitivity;Timepoint(s) of evaluation of this end point: After surgery

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Secondary

Measure	Time frame
Secondary end point(s): Specificity,error rate,positive and negative likilihood ratios of PET-CT to CHT;Timepoint(s) of evaluation of this end point: After surgery	—

Countries

France

Contacts

Public ContactRenaud CIAPPUCCINI

Centre François Baclesse

r.ciappuccini@baclesse.unicancer.fr33231455032

Outcome results

None listed