NCT02784223
Completed
Not Applicable
Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study
Centre Francois Baclesse1 site in 1 country107 target enrollmentMay 2016
ConditionsThyroid Gland
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thyroid Gland
- Sponsor
- Centre Francois Baclesse
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Sensitivity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
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 Outcomes
- Predictive diagnostic capabilities(Up to 4 months)
- Duration for acquisition(Up to 4 months)
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
[18F] Fluorocholine FCH Positron Emission Tomography (PET)/Computed Tomography (CT) for Detection of Prostate Cancer Lymph Nodes MetastasesProstate CancerNCT00670527Odense University Hospital205
Completed
Phase 2
Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid AdenomasHyperparathyroidismNCT02432599Centre Francois Baclesse28
Completed
Phase 1
Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate CancerHormone Refractory Prostate CancerNCT00928252Queen's Medical Center25
Active, not recruiting
Phase 1
Diagnostic value of 18F-choline PET/CT for the detection of systemic prostate cancer disease. - 2008-CaP-FCHde novo patients with histologically confirmed prostate cancerMedDRA version: 12.0Level: LLTClassification code 10060862Term: Prostate cancerEUCTR2009-014839-21-FRCIS bio international, member of IBA group150
Completed
Phase 3
The Safety and Efficacy of 18F-Fluoromethylcholine (18F-FCH) PET/CT in Prostate CancerProstate CancerNCT02840552Sir Mortimer B. Davis - Jewish General Hospital60