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

NCT ID: NCT03498183

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-17
• Study Completion Date: 2025-05-07

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.

Conditions

Malignancy of Thyroid Nodules

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ARM experimental

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

Group Type: EXPERIMENTAL

MIBI-Tc99m/Iodine-123

Intervention Type: DRUG

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

Interventions

MIBI-Tc99m/Iodine-123

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

hopital Avicenne

Bobigny, , France

CHU

Lille, , France

CHU

Limoges, , France

Hospices Civils

Lyon, , France

CHU

Nantes, , France

Assistance publique des Hôpitaux de Paris

Paris, , France

Institut Curie

Paris, , France

Countries

France

Other Identifiers

RC18_0052

Identifier Type: -

Identifier Source: org_study_id