Clinical trial NCT03498183: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Malignancy of Thyroid Nodules
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the patients will have the scintigraphie with MIBI-Tc99m/Iodine-123
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Month 36
Secondary outcomes:
measure: Evaluation of the correlation between dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).
timeFrame: Month 36
measure: Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
timeFrame: Month 36
measure: Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
timeFrame: Month 36
measure: Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
timeFrame: Month 36
measure: Evaluation of diagnostics properties of Ti-RADS scoring.
timeFrame: Month 36
measure: Evaluation of diagnostics properties of Ti-RADS scoring.
timeFrame: Month 36
measure: Evaluation of diagnostics properties of Ti-RADS scoring.
timeFrame: Month 36
measure: Evaluation of diagnostics properties of the best combination of the scintigraphic values (intensity of MIBI and Iodine uptakes) to improve the diagnostic properties.
timeFrame: Month 36
measure: Evaluation of the MIBI washout
timeFrame: Month 36
measure: Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.
timeFrame: Month 36
measure: Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.
timeFrame: year 10
Other outcomes:
Locations:
city: Bobigny
country: France
facility: hopital Avicenne
city: Lille
country: France
facility: CHU
city: Limoges
country: France
facility: CHU
city: Lyon
country: France
facility: Hospices Civils
city: Nantes
country: France
facility: CHU
city: Paris
country: France
facility: Assistance publique des Hôpitaux de Paris
city: Paris
country: France
facility: Institut Curie
Study officials:
References: