MIBI-THYR: Value of the Combination Ultrasonography With Ti-RADS Score / Dual Tracer Scintigraphy MIBI-Tc99m/Iodine-123 in the Detection of Malignancy of Thyroid Nodules (≥15 mm) Classified Bethesda III or IV on Cytology
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ARM experimental All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy. |
Drug: MIBI-Tc99m/Iodine-123
Following the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy.
|
Outcome Measures
Primary Outcome Measures
- 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. [Month 36]
Scintigraphy MIBI-Tc99m/Iodine-123
Secondary Outcome Measures
- Evaluation of the correlation between dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score). [Month 36]
Spearman's correlation coefficient between measures obtained using dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).
- Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy. [Month 36]
Estimation of the sensitivity of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
- Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy. [Month 36]
Estimation of the specificity value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
- Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy. [Month 36]
Estimation of the positive predictive value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
- Evaluation of diagnostics properties of Ti-RADS scoring. [Month 36]
Quality of life measured using the scores of the SF36 questionnaire
- Evaluation of diagnostics properties of Ti-RADS scoring. [Month 36]
Quality of life measured using an evaluation of the voice measured using a specific autoquestionnaire
- Evaluation of diagnostics properties of Ti-RADS scoring. [Month 36]
Quality of life measured using the scores of EQ-5D questionnaire
- Evaluation of diagnostics properties of the best combination of the scintigraphic values (intensity of MIBI and Iodine uptakes) to improve the diagnostic properties. [Month 36]
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")
- Evaluation of the MIBI washout [Month 36]
MIBI washout estimated using the percentage reduction value of mean MIBI uptake between early (10 min) and late (>60 min) scans
- Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery. [Month 36]
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.
- Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery. [year 10]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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Given signed, written informed consent
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Affiliation to a social security system.
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Neither-pregnant nor breast-feeding women.
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Use of efficient contraception for patient with pregnancy potential (if needed).
Exclusion Criteria:
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Underage and adults under guardianship.
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Pregnant, without efficient contraception (if needed) or breast feeding women.
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Administration of iodinated contrast in the previous 3 weeks.
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Contraindication to scintigraphy or to Iodine123/ MIBI 99Tc administration
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Treatment containing iodine (i.e. : Amiodarone)
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Hypo or hyperthyroidism treated or not.
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Nodules inferior 15 mm.
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Refusal to sign the consent.
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Refusal of surgical treatment or contraindication for surgery or anesthesia
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Morbid obesity (BMI Superior 40 kg/m2).
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Hyperparathyroidism.
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History of cervicotomy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier et Universitaire (chu) | Angers | France | 49000 | |
| 2 | CHU | Grenoble | France | 38000 | |
| 3 | CHU | Lille | France | 59000 | |
| 4 | CHU | Limoges | France | ||
| 5 | Hospices Civils | Lyon | France | 69000 | |
| 6 | CHU | Nantes | France | ||
| 7 | Assistance publique des Hôpitaux de Paris | Paris | France | 75 000 |
Sponsors and Collaborators
- Nantes University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC18_0052