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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM experimental | Experimental | All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIBI-Tc99m/Iodine-123 | Drug | Following the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Month 36 |
| Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hopital Avicenne | Bobigny | 93000 | France | |||
| CHU |
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All the patients will have the scintigraphie with MIBI-Tc99m/Iodine-123
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Estimation of the sensitivity of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy. |
| 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. | 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. | Month 36 |
| Evaluation of diagnostics properties of Ti-RADS scoring. | Quality of life measured using the scores of the SF36 questionnaire | 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 | Month 36 |
| Evaluation of diagnostics properties of Ti-RADS scoring. | Quality of life measured using the scores of EQ-5D questionnaire | 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") | 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 | 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. | 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. | year 10 |
| Lille |
| 59000 |
| France |
| CHU | Limoges | France |
| Hospices Civils | Lyon | 69000 | France |
| CHU | Nantes | France |
| Assistance publique des Hôpitaux de Paris | Paris | 75 000 | France |
| Institut Curie | Paris | 75005 | France |
| ID | Term |
|---|---|
| C000614958 | Iodine-123 |
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