The main objective of the study is to show that the addition of ultrasonography to the dual tracer scintigraphy MIBI-Tc99m/Iodine-123 will increase (at least +5%) the negative predictive value compared to the dual tracer scintigraphy alone in detection of malignancy in thyroid nodules ≥15 mm classified as Bethesda III-IV on cytology.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
372
Following the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy.
hopital Avicenne
Bobigny, France
CHU
Lille, France
CHU
Limoges, France
Hospices Civils
Lyon, France
CHU
Nantes, France
Assistance publique des Hôpitaux de Paris
Paris, France
Institut Curie
Paris, France
Addition of ultrasonography to the dual tracer scintigraphy MIBI-Tc99m/Iodine-123 will increase the negative predictive value compared to the dual tracer scintigraphy alone.
Scintigraphy MIBI-Tc99m/Iodine-123
Time frame: Month 36
Evaluation of the correlation between dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).
Spearman's correlation coefficient between measures obtained using dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).
Time frame: Month 36
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Estimation of the sensitivity of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Time frame: Month 36
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Estimation of the specificity value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Time frame: Month 36
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Estimation of the positive predictive value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Time frame: Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.
Quality of life measured using the scores of the SF36 questionnaire
Time frame: Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.
Quality of life measured using an evaluation of the voice measured using a specific autoquestionnaire
Time frame: Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.
Quality of life measured using the scores of EQ-5D questionnaire
Time frame: Month 36
Evaluation of diagnostics properties of the best combination of the scintigraphic values (intensity of MIBI and Iodine uptakes) to improve the diagnostic properties.
Research of the best thresholds on scintigraphic values (intensity of MIBI and Iodine uptakes) to improve the diagnostic properties (details of scores are given in "5.3.3. Role of Nuclear Medicine Physician")
Time frame: Month 36
Evaluation of the MIBI washout
MIBI washout estimated using the percentage reduction value of mean MIBI uptake between early (10 min) and late (\>60 min) scans
Time frame: Month 36
Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.
Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY) of the comparison between the systematic surgery strategy to the non-systematic surgery strategy guided by imagery over a 10 years' time horizon.
Time frame: Month 36
Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.
Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY) of the comparison between the systematic surgery strategy to the non-systematic surgery strategy guided by imagery over a 10 years' time horizon.
Time frame: year 10
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