Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

MIBI-THYR : 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

This research, called MIBI-THYR, is exploring better ways to figure out if thyroid lumps, called nodules, are cancerous or not. It specifically focuses on nodules that are 15mm or larger and have had a biopsy result of Bethesda III or IV, which means they are unclear. The study combines two types of scanning tests: a detailed ultrasound with a special scoring system (Ti-RADS) and special imaging tests using MIBI-Tc99m and Iodine-123. The goal is to see if combining these tests can give doctors a more accurate picture, helping them decide if surgery is really needed. This could mean fewer people having operations for lumps that turn out not to be cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Centre Hospitalier Universitaire De Nantes

Enrolment target

375

Start

07 Oct 2024

malignancy of thyroid nodules

What is this study about?

When doctors find a lump in your thyroid gland, it's called a thyroid nodule. Sometimes, a small sample (biopsy) is taken from the lump to check if it's cancerous. However, some biopsy results, like Bethesda III or IV, can be a bit unclear, making it hard to tell for sure if the lump is serious or not. This often means people might need surgery to remove the lump, even if it turns out to be harmless.

This study, called MIBI-THYR, is trying to improve how doctors make these decisions. It's looking at whether using a combination of different scanning tests can give a clearer answer. The main idea is to use a detailed ultrasound scan, which creates pictures of the lump using sound waves, along with a special scoring system to help interpret what's seen. This is paired with another type of scan that uses very small amounts of special tracers (MIBI-Tc99m and Iodine-123) to see how the thyroid lump behaves.

The main aim is to see if combining these scans can help doctors be more certain about whether a thyroid lump is cancerous or not, especially for those unclear Bethesda III or IV results. If successful, this could mean fewer people having to go through surgery unnecessarily, and those who do need surgery can get the right treatment sooner. It's about finding the best way to diagnose these lumps without causing too much worry or having unnecessary procedures.

Key takeaways

This study aims to improve diagnosis of unclear thyroid lumps.
It combines ultrasound with a special score and advanced tracer scans.
The goal is to reduce unnecessary surgeries for thyroid nodules.
It focuses on adults with thyroid lumps that are 15mm or larger and have 'unclear' biopsy results (Bethesda III or IV).
Participation involves medical appointments and diagnostic scans, not new medications.

Who may be eligible?

This study is open to adults aged 18 years and older, with no upper age limit. Both men and women can take part.

To be eligible, you must have a thyroid lump (nodule) that is at least 15 millimetres (about half an inch) in size. Importantly, a previous biopsy of this lump must have given an unclear result, specifically classified as Bethesda III or IV.

Your doctor will be able to check if your specific health situation and your thyroid lump's characteristics meet all the detailed requirements for joining this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a thyroid lump (nodule)?
Is your thyroid lump 15 millimetres (about 0.6 inches) or larger?
Has a biopsy of your lump been classified as Bethesda III or Bethesda IV (meaning 'unclear')?
Are you able to attend appointments for medical scans?

Answer every question to see your result.

What does participation involve?

The detailed description of what taking part involves is not provided in the brief summary. However, typically for studies like this, participants would undergo a series of medical appointments. These usually include a thorough check-up, blood tests, and the two types of imaging scans mentioned: an ultrasound of your thyroid and a dual tracer scintigraphy (MIBI-Tc99m/Iodine-123 scan). You would not be given any new medication as part of this study, as it focuses on diagnostic tests. The total duration of your involvement could vary depending on the follow-up needed, but the main testing phase would likely be completed within a short period, possibly a few weeks or months. You would continue to receive care from your usual doctor.

Potential risks and benefits

Taking part in this study could help advance medical understanding of thyroid lumps, potentially leading to better diagnostic methods in the future. You might benefit from a more thorough evaluation of your thyroid nodule using advanced imaging techniques. Potential risks include those associated with any medical scan, such as exposure to small amounts of radiation from the scintigraphy scans (which is carefully controlled and kept as low as possible), and the minor discomfort of injections for the tracers. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is a thyroid nodule?

A thyroid nodule is simply a lump or growth in your thyroid gland, which is located in your neck. Most are harmless, but some can be cancerous.

What does 'Bethesda III or IV' mean?

These are categories used after a biopsy of a thyroid lump. They mean the result is unclear, and doctors can't definitively say if the lump is cancerous or not just from the biopsy alone.

What is an ultrasound scan?

An ultrasound uses sound waves to create pictures of the inside of your body. It's a common, painless scan that doesn't use radiation.

What are the MIBI-Tc99m/Iodine-123 scans?

These are special imaging tests that use tiny, safe amounts of radioactive tracers to show how your thyroid gland and the nodule are working. They can help doctors see if the lump is acting differently from normal thyroid tissue.

Will I get medication in this study?

No, this study is about diagnostic tests, not new medications. You will not be given any experimental drugs as part of your participation.