Back to resultsDiagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study (CHOCOLATE)
Primary Purpose
Thyroid Gland
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiation : PET-CT with F18-choline examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Gland focused on measuring F18-choline, Surgery, Indeterminate, Thyroid node
Eligibility Criteria
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
Sites / Locations
- Centre François Baclesse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET-CT with F18-choline
Arm Description
PET-CT with F18-choline examination will be performed before surgery
Outcomes
Primary Outcome Measures
Sensitivity
Sensitivity of 18F-choline PET to detect the cases of thyroid cancer among patients with thyroid nodule with an indeterminate cytology.
Specificity
Specificity of 18F-choline PET to detect the cases of thyroid cancer among patients with thyroid nodule with an indeterminate cytology.
Secondary Outcome Measures
Predictive diagnostic capabilities
Diagnostic capabilities of 18F-Choline PET in predicting thyroid cancer
Duration for acquisition
Determination of the optimal duration for the PET acquisition.
Full Information
NCT ID
NCT02784223
First Posted
May 24, 2016
Last Updated
March 28, 2019
Sponsor
Centre Francois Baclesse
Collaborators
Canceropôle Nord Ouest
1. Study Identification
Unique Protocol Identification Number
NCT02784223
Brief Title
Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study
Acronym
CHOCOLATE
Official Title
Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 28, 2019 (Actual)
Study Completion Date
March 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
Canceropôle Nord Ouest
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Gland
Keywords
F18-choline, Surgery, Indeterminate, Thyroid node
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET-CT with F18-choline
Arm Type
Experimental
Arm Description
PET-CT with F18-choline examination will be performed before surgery
Intervention Type
Device
Intervention Name(s)
Radiation : PET-CT with F18-choline examination
Intervention Description
PET-CT with F18-choline examination will be performed before surgery
Primary Outcome Measure Information:
Title
Sensitivity
Description
Sensitivity of 18F-choline PET to detect the cases of thyroid cancer among patients with thyroid nodule with an indeterminate cytology.
Time Frame
Up to 4 months
Title
Specificity
Description
Specificity of 18F-choline PET to detect the cases of thyroid cancer among patients with thyroid nodule with an indeterminate cytology.
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Predictive diagnostic capabilities
Description
Diagnostic capabilities of 18F-Choline PET in predicting thyroid cancer
Time Frame
Up to 4 months
Title
Duration for acquisition
Description
Determination of the optimal duration for the PET acquisition.
Time Frame
Up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33183159
Citation
Ciappuccini R, Licaj I, Lasne-Cardon A, Babin E, de Raucourt D, Blanchard D, Bastit V, Saguet-Rysanek V, Lequesne J, Peyronnet D, Grellard JM, Clarisse B, Bardet S. 18F-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. Thyroid. 2021 May;31(5):800-809. doi: 10.1089/thy.2020.0555. Epub 2020 Dec 23.
Results Reference
derived
Learn more about this trial
Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study
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