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 (MIBI-THYR)

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

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.

Study Overview

• Status: Completed
• Conditions: Malignancy of Thyroid Nodules
• Intervention / Treatment: Drug: MIBI-Tc99m/Iodine-123

• Study Type: Interventional
• Enrollment (Actual): 372
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93000
    • Hôpital Avicenne
  • Lille, France, 59000
    • CHU
  • Limoges, France
    • CHU
  • Lyon, France, 69000
    • Hospices Civils
  • Nantes, France
    • CHU
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75 000
    • Assistance publique des Hôpitaux de Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM experimental; All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy.	Drug: MIBI-Tc99m/Iodine-123; Following the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Scintigraphy MIBI-Tc99m/Iodine-123	Month 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the correlation between dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).	Spearman's correlation coefficient between measures obtained using dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).	Month 36
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.	Estimation of the sensitivity of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.	Month 36
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.	Estimation of the specificity value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.	Month 36
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.	Estimation of the positive predictive value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.	Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.	Quality of life measured using the scores of the SF36 questionnaire	Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.	Quality of life measured using an evaluation of the voice measured using a specific autoquestionnaire	Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.	Quality of life measured using the scores of EQ-5D questionnaire	Month 36
Evaluation of diagnostics properties of the best combination of the scintigraphic values (intensity of MIBI and Iodine uptakes) to improve the diagnostic properties.	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")	Month 36
Evaluation of the MIBI washout	MIBI washout estimated using the percentage reduction value of mean MIBI uptake between early (10 min) and late (>60 min) scans	Month 36
Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.	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.	Month 36
Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.	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.	year 10

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Actual): May 7, 2025
• Study Completion (Actual): May 7, 2025

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: April 6, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Thyroid Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Neoplasms; Thyroid Nodule
• Other Study ID Numbers: RC18_0052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No