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Completed

NCT Number: NCT03498183

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

hopital Avicenne, Bobigny, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MIBI-Tc99m/Iodine-123

Drug

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

Primary outcomes

  1. 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.

    Time frame: Month 36

    Scintigraphy MIBI-Tc99m/Iodine-123

Secondary outcomes

  1. Evaluation of the correlation between dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).

    Time frame: Month 36

    Spearman's correlation coefficient between measures obtained using dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).

  2. Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.

    Time frame: Month 36

    Estimation of the sensitivity of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.

  3. Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.

    Time frame: Month 36

    Estimation of the specificity value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.

  4. Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.

    Time frame: Month 36

    Estimation of the positive predictive value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.

  5. Evaluation of diagnostics properties of Ti-RADS scoring.

    Time frame: Month 36

    Quality of life measured using the scores of the SF36 questionnaire

  6. Evaluation of diagnostics properties of Ti-RADS scoring.

    Time frame: Month 36

    Quality of life measured using an evaluation of the voice measured using a specific autoquestionnaire

  7. Evaluation of diagnostics properties of Ti-RADS scoring.

    Time frame: Month 36

    Quality of life measured using the scores of EQ-5D questionnaire

  8. Evaluation of diagnostics properties of the best combination of the scintigraphic values (intensity of MIBI and Iodine uptakes) to improve the diagnostic properties.

    Time frame: 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")

  9. Evaluation of the MIBI washout

    Time frame: Month 36

    MIBI washout estimated using the percentage reduction value of mean MIBI uptake between early (10 min) and late (>60 min) scans

  10. Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.

    Time frame: Month 36

    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.

  11. Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: MIBI-THYR

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2018
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.