Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 29, 2018
First Posted Date  ICMJE April 13, 2018
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE January 17, 2019
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03498183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
  • 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).
  • 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.
  • 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.
  • 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.
  • Evaluation of diagnostics properties of Ti-RADS scoring. [ Time Frame: Month 36 ]
    Quality of life measured using the scores of the SF36 questionnaire
  • 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
  • Evaluation of diagnostics properties of Ti-RADS scoring. [ Time Frame: Month 36 ]
    Quality of life measured using the scores of EQ-5D questionnaire
  • 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")
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2018)
  • 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).
  • 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.
  • 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.
  • 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.
  • Evaluation of diagnostics properties of Ti-RADS scoring. [ Time Frame: Month 36 ]
    Quality of life measured using the scores of the SF36 questionnaire
  • 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
  • Evaluation of diagnostics properties of Ti-RADS scoring. [ Time Frame: Month 36 ]
    Quality of life measured using the scores of EQ-5D questionnaire
  • 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")
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Malignancy of Thyroid Nodules
Intervention  ICMJE Drug: MIBI-Tc99m/Iodine-123
Following the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy.
Study Arms  ICMJE Experimental: ARM experimental
All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy.
Intervention: Drug: MIBI-Tc99m/Iodine-123
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2018)
321
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03498183
Other Study ID Numbers  ICMJE RC18_0052
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP