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

Thyroid Gland Clinical Trial

— CHOCOLATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784223
• Other study ID #: CHOCOLATE
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: March 28, 2019

Study information

• Verified date: March 2019
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 28, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Gland
• Thyroid Nodule

Intervention

Device:
• Radiation : PET-CT with F18-choline examination
PET-CT with F18-choline examination will be performed before surgery

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Canceropôle Nord Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Predictive diagnostic capabilities	Diagnostic capabilities of 18F-Choline PET in predicting thyroid cancer	Up to 4 months
Secondary	Duration for acquisition	Determination of the optimal duration for the PET acquisition.	Up to 4 months