307 [18F]FDG-PET/CT to prevent futile surgery: a blinded, randomised controlled multicentre trial 4 Table 2. Reasons for patient ineligibility for study participation Patients not fulfilling inclusion criteria 48 Diagnostic surgery not scheduled/recommended yet* 13 Repeat FNAC Bethesda II 5 Repeat FNAC Bethesda VI 1 Unknown follow-up, no study inclusion 7 Patient preferred diagnostic surgery to study participation 11 Patient preferred surveillance to study participation 1 First presentation with suspicious cervical lymphadenopathy 3 Initial diagnosis of the nodule as an [18F]FDG-positive thyroid incidentaloma on [18F]FDG-PET/CT 1 Patient had any non-routine diagnostics (e.g., mutation analysis, [18F]FDG-PET/CT outside study) 5 Language barrier 3 Patient under 18 years old 1 Comorbidities / medical history 9 Pregnant 1 Patient did not want to participate in (all aspects of) the study 34 Reason unknown to researchers, not reported by local physician 31 TOTAL ineligible patients 113 *: In most of these cases, diagnostic surgery was not scheduled/recommended yet because patients only had one Bethesda III result. According to current guidelines, repeat FNAC is recommended before considering diagnostic surgery. Figure 2. Included patients per study site and allocated group
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