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 个研究点目标入组 132 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•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
•case of a suppressed TSH: a negative 123I, 131I or 99mTcO4- scintigraphy must
•be available (*cold nodule*);
•5. In patients with multi-nodular disease and a dominant nodule, the nuclear
•medicine physician responsible for FDG-PET/CT scan interpretation must
•determine whether the nodule is likely to be discriminated on FDG-PET/CT
•imaging prior to enrolment;
•6. Willing to participate in all aspects of the study;

•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)
•4. inability to undergo randomisation (i.e. scheduled thyroid resection for
•other than diagnostic purposes)
•5. inability to undergo treatment (i.e. inoperable patients)
•6. Contra-indications for FDG-PET/CT (e.g. recent neck infection, poorly
•regulated diabetes mellitus, pregnant, lactating, severely claustrophobic, etc.)
•7. General (inability of informed consent, severe psychiatric disorder)

发起方

Radiologie & Nucleaire Geneeskunde