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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)

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ClinicalTrials.gov Identifier: NCT03498183
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignancy of Thyroid Nodules Drug: MIBI-Tc99m/Iodine-123 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 321 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All the patients will have the scintigraphie with MIBI-Tc99m/Iodine-123
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498183


Contacts
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Contact: Eric Mirallié, MD 02.40.08.49.78 eric/mirallie@chu-nantes.fr
Contact: Nelly Renaud-Moreau 02.40.08.49.78 Nelly.RENAUDMOREAU@chu-nantes.fr

Locations
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France
Centre Hospitalier et Universitaire (chu) Not yet recruiting
Angers, France, 49000
Contact: HAMY       Anhamy@chu-angers.fr   
CHU Not yet recruiting
Grenoble, France, 38000
Contact: chaffanjon       Pchaffanjon@chu-grenoble.fr'   
CHU Not yet recruiting
Lille, France, 59000
Contact: Pattou       'Fpattou@univ-lille2.fr   
CHU Not yet recruiting
Limoges, France
Contact: Mathonnet       Mathonnet@unilim.fr   
Hospices Civils Not yet recruiting
Lyon, France, 69000
Contact: Lifante       'Jean-christophe.lifante@chu-lyon.fr   
CHU Recruiting
Nantes, France
Contact: Eric Mirallié       eric.mirallie@chu-nantes.fr   
Assistance publique des Hôpitaux de Paris Not yet recruiting
Paris, France, 75 000
Contact: Fabrice Menegaux       Fabrice.menegaux@psl.aphp.fr   
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03498183     History of Changes
Other Study ID Numbers: RC18_0052
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Neoplasms
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs