Papillary Thyroid MicrocarcinomaMIPA-MITTNCT06333587
Minimally Invasive Treatments of the Thyroid
An observational study of Papillary Thyroid Microcarcinoma, run by European Institute of Oncology at 1 site in Italy.
Trial summary
This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Microcarcinoma
- What is being tested?
- image-guided thermal ablation
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2022to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with thyroid diseases suitable for "Minimally Invasive Treatments of the Thyroid (MITT)" as potential alternative to surgery
Who may be able to join
- Patients > 18years
- Patients with diagnosis of papillary thyroid microcarcinoma, citologically proven, suitable for MITT.
- Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
- Patients must be accessible for follow-up
Who cannot join
- Tumors > 1 cm, other citological type, refusal of MITT, unsuitable for MITT, unmanageable coagulative disorders
- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Giovanni Mauri
About this study
Official title: Multicenter International Prospective Analysis on Minimally Invasive Treatments of the Thyroid (MIPA- MITT) of of Micropapillary Thyroid Carcinoma
This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC)
Read the detailed description
Image-guided thermal ablations have been successfully applied in the treatment of several type of tumors, and have been recently proposed as a potential alternative to surgery also in patients with thyroid diseases, and named "Minimally Invasive Treatments of the Thyroid (MITT)". These minimally invasive treatments, compared to surgical treatment have similar efficacy, fewer complications, better quality of life, and better cosmetic outcomes. These procedures allow precise delivery of the heat locally to the lesion, sparing the surrounding thyroid tissue, and thus minimizing the invasiveness of the treatment and the impact on thyroid function.
This study aim to establish a prospective registry of the cases of patients treated with MITT for a Papillary Thyroid MicroCarcinoma (PTMC), in order to validate the safety of the procedure and to set the basis for collecting long term results in a large cohort of patients.
- Conditions
- Papillary Thyroid Microcarcinoma
- Being tested
- image-guided thermal ablation
- Medical subject headings
- Papillary Thyroid Microcarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
image-guided thermal ablationProcedure or surgery
image-guided thermal ablation in patients with diagnosis of micropapillary thyroid carcinoma
| Study group | Role | What they receive |
|---|---|---|
| image-guided thermal ablation | image-guided thermal ablation in patients with diagnosis of micropapillary thyroid carcinoma Receives: Procedure: image-guided thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with major complications occurring within one month after the date of intervention
Complications will be reported according to modified Society of Interventional Radiology (SIR) classification
Measured: 1 month
Secondary outcomes (3)
Percentage of patients with local recurrence at 10 years
Evaluation of disease free survival (DFS): percentage of patient whith a local recurrence at 10 years of follow up
Measured: 10 years
Percentage of patients with distant metastasis at 10 years
Evaluation of disease free survival (DFS): percentage of patient whith distant metastasis at 10 years of follow up
Measured: 10 years
Percentage of patients died at 10 years
Evaluation of Overall Survival (OS): Percentage of patients died at 10 years
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start10 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid MicrocarcinomaStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Mauri, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333587
- Sponsor's protocol ID
- IEO 1810
- Acronym
- MIPA-MITT
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter International Prospective Analysis on Minimally Invasive Treatments of the Thyroid (MIPA- MITT) of of Micropapillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT06333587
- Acronym / sponsor ID
- MIPA-MITT / IEO 1810
- Conditions
- Papillary Thyroid Microcarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 27 Mar 2024 (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.
This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC)
Detailed description
Image-guided thermal ablations have been successfully applied in the treatment of several type of tumors, and have been recently proposed as a potential alternative to surgery also in patients with thyroid diseases, and named "Minimally Invasive Treatments of the Thyroid (MITT)". These minimally invasive treatments, compared to surgical treatment have similar efficacy, fewer complications, better quality of life, and better cosmetic outcomes. These procedures allow precise delivery of the heat locally to the lesion, sparing the surrounding thyroid tissue, and thus minimizing the invasiveness of the treatment and the impact on thyroid function.
This study aim to establish a prospective registry of the cases of patients treated with MITT for a Papillary Thyroid MicroCarcinoma (PTMC), in order to validate the safety of the procedure and to set the basis for collecting long term results in a large cohort of patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| image-guided thermal ablation | – | Procedure: image-guided thermal ablationimage-guided thermal ablation in patients with diagnosis of micropapillary thyroid carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thyroid diseases suitable for "Minimally Invasive Treatments of the Thyroid (MITT)" as potential alternative to surgery
Key inclusion criteria (4 listed)
- Patients > 18years
- Patients with diagnosis of papillary thyroid microcarcinoma, citologically proven, suitable for MITT.
- Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
- Patients must be accessible for follow-up
Key exclusion criteria (2 listed)
- Tumors > 1 cm, other citological type, refusal of MITT, unsuitable for MITT, unmanageable coagulative disorders
- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
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 |
|---|---|---|
| image-guided thermal ablationimage-guided thermal ablation in patients with diagnosis of micropapillary thyroid carcinoma | Procedure or surgery | image-guided thermal ablation |
Primary outcome
The proportion of patients with major complications occurring within one month after the date of intervention
Time frame: 1 month
Complications will be reported according to modified Society of Interventional Radiology (SIR) classification
3 secondary outcomes
Percentage of patients with local recurrence at 10 years
Time frame: 10 years
Percentage of patients with distant metastasis at 10 years
Time frame: 10 years
Percentage of patients died at 10 years
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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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.
Giovanni Mauri principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillary Thyroid Microcarcinoma, run by European Institute of Oncology at 1 site in Italy.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Mauri (+390294372691, giovanni.mauri@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with major complications occurring within one month after the date of intervention (time frame: 1 month). 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 27 Mar 2024.