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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02784223

Acronym

CHOCOLATE

Enrollment

107

Registered

2016-05-27

Start date

2016-05-31

Completion date

2019-03-28

Last updated

2019-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Gland

Keywords

F18-choline, Surgery, Indeterminate, Thyroid node

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.

Interventions

DEVICERadiation : PET-CT with F18-choline examination

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026