Back to resultsValue 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)
Primary Purpose
Malignancy of Thyroid Nodules
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
MIBI-Tc99m/Iodine-123
Sponsored by
About this trial
This is an interventional diagnostic trial for Malignancy of Thyroid Nodules
Eligibility 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.
Sites / Locations
- Centre Hospitalier et Universitaire (chu)
- CHU
- CHU
- CHU
- Hospices Civils
- CHURecruiting
- Assistance publique des Hôpitaux de Paris
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARM experimental
Arm Description
All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
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.
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.
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.
Evaluation of diagnostics properties of Ti-RADS scoring.
Quality of life measured using the scores of the SF36 questionnaire
Evaluation of diagnostics properties of Ti-RADS scoring.
Quality of life measured using an evaluation of the voice measured using a specific autoquestionnaire
Evaluation of diagnostics properties of Ti-RADS scoring.
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.
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
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.
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.
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.
Full Information
NCT ID
NCT03498183
First Posted
March 29, 2018
Last Updated
February 8, 2021
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03498183
Brief 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 (≥15 mm) Classified Bethesda III or IV on Cytology
Acronym
MIBI-THYR
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignancy of Thyroid Nodules
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
All the patients will have the scintigraphie with MIBI-Tc99m/Iodine-123
Masking
None (Open Label)
Allocation
N/A
Enrollment
321 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ARM experimental
Arm Type
Experimental
Arm Description
All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy.
Intervention Type
Drug
Intervention Name(s)
MIBI-Tc99m/Iodine-123
Intervention Description
Following the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy.
Primary Outcome Measure Information:
Title
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.
Description
Scintigraphy MIBI-Tc99m/Iodine-123
Time Frame
Month 36
Secondary Outcome Measure Information:
Title
Evaluation of the correlation between dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).
Description
Spearman's correlation coefficient between measures obtained using dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).
Time Frame
Month 36
Title
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Description
Estimation of the sensitivity of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Time Frame
Month 36
Title
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Description
Estimation of the specificity value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Time Frame
Month 36
Title
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Description
Estimation of the positive predictive value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Time Frame
Month 36
Title
Evaluation of diagnostics properties of Ti-RADS scoring.
Description
Quality of life measured using the scores of the SF36 questionnaire
Time Frame
Month 36
Title
Evaluation of diagnostics properties of Ti-RADS scoring.
Description
Quality of life measured using an evaluation of the voice measured using a specific autoquestionnaire
Time Frame
Month 36
Title
Evaluation of diagnostics properties of Ti-RADS scoring.
Description
Quality of life measured using the scores of EQ-5D questionnaire
Time Frame
Month 36
Title
Evaluation of diagnostics properties of the best combination of the scintigraphic values (intensity of MIBI and Iodine uptakes) to improve the diagnostic properties.
Description
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")
Time Frame
Month 36
Title
Evaluation of the MIBI washout
Description
MIBI washout estimated using the percentage reduction value of mean MIBI uptake between early (10 min) and late (>60 min) scans
Time Frame
Month 36
Title
Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.
Description
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.
Time Frame
Month 36
Title
Cost-effectiveness analysis (economic efficiency) at 10 years comparing the systematic surgery strategy to the non-systematic strategy guided by imagery.
Description
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.
Time Frame
year 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Mirallié, MD
Phone
02.40.08.49.78
Email
eric/mirallie@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nelly Renaud-Moreau
Phone
02.40.08.49.78
Email
Nelly.RENAUDMOREAU@chu-nantes.fr
Facility Information:
Facility Name
Centre Hospitalier et Universitaire (chu)
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HAMY
Email
Anhamy@chu-angers.fr
Facility Name
CHU
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chaffanjon
Email
Pchaffanjon@chu-grenoble.fr'
Facility Name
CHU
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pattou
Email
'Fpattou@univ-lille2.fr
Facility Name
CHU
City
Limoges
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathonnet
Email
Mathonnet@unilim.fr
Facility Name
Hospices Civils
City
Lyon
ZIP/Postal Code
69000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lifante
Email
'Jean-christophe.lifante@chu-lyon.fr
Facility Name
CHU
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Mirallié
Email
eric.mirallie@chu-nantes.fr
Facility Name
Assistance publique des Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75 000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Menegaux
Email
Fabrice.menegaux@psl.aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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