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

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Cadexomer iodine; Iodine

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.