Malignancy of Thyroid NodulesPhase 2/3MIBI-THYRNCT03498183
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
A Phase 2/3 study testing MIBI-Tc99m/Iodine-123 in people with Malignancy of Thyroid Nodules, run by Nantes University Hospital at 7 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy of Thyroid Nodules
- What is being tested?
- MIBI-Tc99m/Iodine-123
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 7 sitesFrance
- Study dates
- 17 Jan 2019to 7 May 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
hopital Avicenne
Bobigny, 93000
CHU
Lille, 59000
CHU
Limoges
Hospices Civils
Lyon, 69000
CHU
Nantes
Assistance publique des Hôpitaux de Paris
Paris, 75 000
Institut Curie
Paris, 75005
About this study
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
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.
- Conditions
- Malignancy of Thyroid Nodules
- Being tested
- MIBI-Tc99m/Iodine-123
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIBI-Tc99m/Iodine-123Drug
Following the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy.
| Study group | Role | What they receive |
|---|---|---|
| ARM experimental | Experimental | All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy. Receives: Drug: MIBI-Tc99m/Iodine-123 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 36
Secondary outcomes (11)
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).
Measured: Month 36
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.
Measured: Month 36
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.
Measured: Month 36
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.
Measured: Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.
Quality of life measured using the scores of the SF36 questionnaire
Measured: Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.
Quality of life measured using an evaluation of the voice measured using a specific autoquestionnaire
Measured: Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.
Quality of life measured using the scores of EQ-5D questionnaire
Measured: Month 36
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")
Measured: Month 36
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
Measured: Month 36
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.
Measured: Month 36
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.
Measured: year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start17 Jan 2019
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignancy of Thyroid NodulesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All the patients will have the scintigraphie with MIBI-Tc99m/Iodine-123
- Masking
- None (open label)
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498183
- Sponsor's protocol ID
- RC18_0052
- Acronym
- MIBI-THYR
- Status last verified
- Jun 2025
- First submitted
- 29 Mar 2018
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03498183
- Acronym / sponsor ID
- MIBI-THYR / RC18_0052
- Conditions
- Malignancy of Thyroid Nodules
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the patients will have the scintigraphie with MIBI-Tc99m/Iodine-123
| Arm | Type | Receives |
|---|---|---|
| ARM experimental | Experimental | Drug: MIBI-Tc99m/Iodine-123All the patients will have MIBI-Tc99m/Iodine-123 . Following the injections they will have a scintigraphy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIBI-Tc99m/Iodine-123Following the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy. | Drug | ARM experimental |
Primary outcome
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
11 secondary outcomes
Evaluation of the correlation between dual scintigraphy (MIBI/Iodine-123) and cervical ultrasonography (with Ti-RADS score).
Time frame: Month 36
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Time frame: Month 36
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Time frame: Month 36
Evaluation of diagnostics properties of MIBI/Iodine-123 scintigraphy for detection of thyroid malignancy.
Time frame: Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.
Time frame: Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.
Time frame: Month 36
Evaluation of diagnostics properties of Ti-RADS scoring.
Time frame: Month 36
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
Evaluation of the MIBI washout
Time frame: Month 36
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MIBI-Tc99m/Iodine-123 in people with Malignancy of Thyroid Nodules, run by Nantes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.