NCT03498183CompletedPhase 2/3
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 · Last updated 6 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 372 (actual)
- First submitted
- 29 Mar 2018
- Start date
- 17 Jan 2019
- Primary completion date
- 7 May 2025
- Lead sponsor
- Nantes University Hospital
- Diseases
- Thyroid cancer
- NCT number
- NCT03498183
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 372
- From 17 Jan 2019 to the primary completion date, 7 May 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Administration of iodinated contrast in the previous 3 weeks.
- Refusal of surgical treatment or contraindication for surgery or anesthesia
Other illness
- History of cervicotomy.
Other
- Underage and adults under guardianship.
- Pregnant, without efficient contraception (if needed) or breast feeding women.
- 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.
- Morbid obesity (BMI Superior 40 kg/m2).
- Hyperparathyroidism.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
| CHU Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Hospices Civils Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CHU Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Assistance publique des Hôpitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.