Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignancy of Thyroid Nodules | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MIBI-Tc99m/Iodine-123 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARM experimental
- description
- All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy.
- interventionNames
- Drug: MIBI-Tc99m/Iodine-123
Primary outcomes (1)
- measure
- Addition of ultrasonography to the dual tracer scintigraphy MIBI-Tc99m/Iodine-123 will increase the negative predictive value compared to the dual tracer scintigraphy alone.
- timeFrame
- Month 36
- description
- Scintigraphy MIBI-Tc99m/Iodine-123
Secondary outcomes (11)
- measure
- Evaluation of the correlation between dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available