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 (MIBI-THYR)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Malignancy of Thyroid Nodules

Treatments: Drug: MIBI-Tc99m/Iodine-123

Study type: Interventional

Funder types: Other

Identifiers

NCT03498183

RC18_0052

Details and patient eligibility

About

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.

Enrollment: 372 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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372 participants in 1 patient group

ARM experimental

Experimental group

Description:

All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy.

Treatment:

Drug: MIBI-Tc99m/Iodine-123