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

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ClinicalTrials.gov Identifier: NCT02784223
Recruitment Status : Completed
First Posted : May 27, 2016
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
Canceropôle Nord Ouest
Information provided by (Responsible Party):
Centre Francois Baclesse

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.

Condition or disease Intervention/treatment Phase
Thyroid Gland Device: Radiation : PET-CT with F18-choline examination Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study
Study Start Date : May 2016
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : March 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Experimental: PET-CT with F18-choline
PET-CT with F18-choline examination will be performed before surgery
Device: Radiation : PET-CT with F18-choline examination
PET-CT with F18-choline examination will be performed before surgery




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Predictive diagnostic capabilities [ Time Frame: Up to 4 months ]
    Diagnostic capabilities of 18F-Choline PET in predicting thyroid cancer

  2. Duration for acquisition [ Time Frame: Up to 4 months ]
    Determination of the optimal duration for the PET acquisition.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784223


Locations
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France
Centre François Baclesse
Caen, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
Canceropôle Nord Ouest

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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT02784223     History of Changes
Other Study ID Numbers: CHOCOLATE
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Keywords provided by Centre Francois Baclesse:
F18-choline
Surgery
Indeterminate
Thyroid node
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents