Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study
CHOCOLATE
1 other identifier
interventional
107
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 24, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2019
CompletedMarch 29, 2019
March 1, 2019
2.9 years
May 24, 2016
March 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Predictive diagnostic capabilities
Up to 4 months
Duration for acquisition
Up to 4 months
Study Arms (1)
PET-CT with F18-choline
EXPERIMENTALPET-CT with F18-choline examination will be performed before surgery
Interventions
PET-CT with F18-choline examination will be performed before surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- Canceropôle Nord Ouestcollaborator
Study Sites (1)
Centre François Baclesse
Caen, 14076, France
Related Publications (1)
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.
PMID: 33183159DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2016
First Posted
May 27, 2016
Study Start
May 1, 2016
Primary Completion
March 28, 2019
Study Completion
March 28, 2019
Last Updated
March 29, 2019
Record last verified: 2019-03