- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02784223
Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study (CHOCOLATE)
March 28, 2019 updated by: Centre Francois Baclesse
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
107
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Caen, France, 14076
- Centre Francois Baclesse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PET-CT with F18-choline
PET-CT with F18-choline examination will be performed before surgery
|
PET-CT with F18-choline examination will be performed before surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity
Time Frame: 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.
|
Up to 4 months
|
Specificity
Time Frame: 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.
|
Up to 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictive diagnostic capabilities
Time Frame: Up to 4 months
|
Diagnostic capabilities of 18F-Choline PET in predicting thyroid cancer
|
Up to 4 months
|
Duration for acquisition
Time Frame: Up to 4 months
|
Determination of the optimal duration for the PET acquisition.
|
Up to 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
March 28, 2019
Study Completion (Actual)
March 28, 2019
Study Registration Dates
First Submitted
May 24, 2016
First Submitted That Met QC Criteria
May 26, 2016
First Posted (Estimate)
May 27, 2016
Study Record Updates
Last Update Posted (Actual)
March 29, 2019
Last Update Submitted That Met QC Criteria
March 28, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Thyroid Neoplasms
- Thyroid Diseases
- Thyroid Nodule
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Gastrointestinal Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Nootropic Agents
- Lipotropic Agents
- Choline
Other Study ID Numbers
- CHOCOLATE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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