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

Phase 2

Active, not recruiting

• Conditions: Malignancy of Thyroid Nodules
• Interventions: Drug: MIBI-Tc99m/Iodine-123

• Registration Number: NCT03498183
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Study Start: 2019-01-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 372

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARM experimental	MIBI-Tc99m/Iodine-123	All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy.

Primary Outcome Measures

Name	Time	Method
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.	Month 36	Scintigraphy MIBI-Tc99m/Iodine-123

Secondary Outcome Measures

Name	Time	Method
Evaluation of the correlation between dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).	Month 36	Spearman's correlation coefficient between measures obtained using dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.	Month 36	Estimation of the positive predictive value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Evaluation of diagnostics properties of Ti-RADS scoring.	Month 36	Quality of life measured using the scores of EQ-5D questionnaire
Evaluation of the MIBI washout	Month 36	MIBI washout estimated using the percentage reduction value of mean MIBI uptake between early (10 min) and late (\>60 min) scans
Evaluation of diagnostics properties of the best combination of the scintigraphic values (intensity of MIBI and Iodine uptakes) to improve the diagnostic properties.	Month 36	Research of the best thresholds on scintigraphic values (intensity of MIBI and Iodine uptakes) to improve the diagnostic properties (details of scores are given in "5.3.3. Role of Nuclear Medicine Physician")
Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.	year 10	Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY) of the comparison between the systematic surgery strategy to the non-systematic surgery strategy guided by imagery over a 10 years' time horizon.

Trial Locations

Locations (4)

CHU; 🇫🇷 Nantes, France

Hospices Civils; 🇫🇷 Lyon, France

Assistance publique des Hôpitaux de Paris; 🇫🇷 Paris, France

Centre Hospitalier et Universitaire (chu); 🇫🇷 Angers, France