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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignancy of Thyroid Nodules

Interventions

Type	Name	Description
DRUG	MIBI-Tc99m/Iodine-123	Following the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy.

Timeline

• Start date: 2019-01-17
• Primary completion: 2025-05-07
• Completion: 2025-05-07
• First posted: 2018-04-13
• Last updated: 2025-06-06

Locations

7 sites across 1 country: France