Malignancy of Thyroid Nodules Clinical Trial
— MIBI-THYROfficial title:
Value of the Combination Ultrasonography With Ti-RADS Score / Dual Tracer Scintigraphy MIBI-Tc99m/Iodine-123 in the Detection of Malignancy of Thyroid Nodules (Sup or Egal to 15 mm) Classified Bethesda III or IV on Cytology
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.
| Status | Recruiting |
| Enrollment | 321 |
| Est. completion date | July 1, 2021 |
| Est. primary completion date | July 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Any patient over 18 years with a thyroid nodule =15 mm (maximal diameter measured on US) with a Bethesda class III or IV (FNA less than 6 months before the surgery). - Given signed, written informed consent - Affiliation to a social security system. - Neither-pregnant nor breast-feeding women. - Use of efficient contraception for patient with pregnancy potential (if needed). Exclusion Criteria: - Underage and adults under guardianship. - Pregnant, without efficient contraception (if needed) or breast feeding women. - Administration of iodinated contrast in the previous 3 weeks. - Contraindication to scintigraphy or to Iodine123/ MIBI 99Tc administration - Treatment containing iodine (i.e. : Amiodarone) - Hypo or hyperthyroidism treated or not. - Nodules inferior 15 mm. - Refusal to sign the consent. - Refusal of surgical treatment or contraindication for surgery or anesthesia - Morbid obesity (BMI Superior 40 kg/m2). - Hyperparathyroidism. - History of cervicotomy. |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier et Universitaire (chu) | Angers | |
| France | CHU | Grenoble | |
| France | CHU | Lille | |
| France | CHU | Limoges | |
| France | Hospices Civils | Lyon | |
| France | CHU | Nantes | |
| France | Assistance publique des Hôpitaux de Paris | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | 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. | Month 36 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Evaluation of diagnostics properties of Ti-RADS scoring. | Quality of life measured using the scores of the SF36 questionnaire | Month 36 | |
| Secondary | 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 | |
| Secondary | Evaluation of diagnostics properties of Ti-RADS scoring. | Quality of life measured using the scores of EQ-5D questionnaire | Month 36 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |