NL-OMON50212
Completed
Not Applicable
Efficacy of [18F]-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET) in Evaluation of Cytological indeterminate Thyroid nodules prior to Surgery: a multicentre cost-effectiveness study. - EfFECTS
Radiologie & Nucleaire Geneeskunde0 sites132 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- thyroid lump
- Sponsor
- Radiologie & Nucleaire Geneeskunde
- Enrollment
- 132
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Summary of main criteria from protocol v2\.0 paragraph 4\.2:
- •In order to be eligible for participation, a subject must meet ALL of the
- •following criteria:
- •1\. solitary thyroid nodule or dominant thyroid nodulus within multinodular
- •disease, cytologically indeterminate (Bethesda category III or IV)
- •2\. Scheduled for surgical excision (preferably) within 2 months of the
- •inclusion date;
- •3\. Age \* 18 years;
- •4\. Euthyroid state with a serum TSH or a free T4 level within the institutional
- •upper and lower limits of normal, measured within 2 months of registration. In
Exclusion Criteria
- •Summary of main criteria from protocol v2\.0 paragraph 4\.3:
- •A subject who meets ANY of the following criteria will be excluded from
- •participation:
- •1\. high prior probability of malignancy (e.g. proven malignant cytology:
- •Bethesda cat. V or VI, malignant lymphadenopathy, PET positive thyroid
- •incidentaloma, genetic predisposition of thyroid carcinoma, prior radiotherapy
- •to the neck, etc.)
- •2\. proven benign disease or insufficient material for diagnosis (Bethesda cat.
- •3\. performance of additional non\-routine diagnostic tests affecting patient
- •management (e.g. mutation analysis on cytology)
Outcomes
Primary Outcomes
Not specified
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