Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2/Phase 3
Nantes University Hospital (Voir sur ClinicalTrials)
janvier 2019
mai 2025
03 mai 2026
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU - Limoges - France | Contact (sur clinicalTrials) | ||||
| CHU - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils - 69000 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- 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.