MIBI-Tc99m/Iodine-123
DrugFollowing the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy.
NCT Number: NCT03498183
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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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
hopital Avicenne, Bobigny, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Following the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy.
Time frame: Month 36
Scintigraphy MIBI-Tc99m/Iodine-123
Time frame: Month 36
Spearman's correlation coefficient between measures obtained using dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).
Time frame: Month 36
Estimation of the sensitivity 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.
Time frame: Month 36
Estimation of the positive predictive value of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Time frame: Month 36
Quality of life measured using the scores of the SF36 questionnaire
Time frame: Month 36
Quality of life measured using an evaluation of the voice measured using a specific autoquestionnaire
Time frame: Month 36
Quality of life measured using the scores of EQ-5D questionnaire
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")
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
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.
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.
Nantes University Hospital
Other
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
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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.