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RecruitingNAINTERVENTIONAL

The Safety and Feasibility of Radiofrequency Ablation to Treat Low-risk Thyroid Cancer

This study is exploring a new way to treat small, low-risk thyroid cancers (2cm or less) using a method called radiofrequency ablation (RFA). RFA uses heat to shrink the cancerous lump. The main goal is to find out if this treatment is safe and effective, and how well people recover afterwards. Researchers believe RFA could help patients avoid more traditional surgery, like having part of their thyroid removed. Participants will have scans, the RFA procedure, and then follow-up appointments over one year to check their progress. The study also hopes to show that people maintain a good quality of life after RFA and avoid problems like an underactive thyroid. This research aims to offer a less invasive option for suitable patients.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Health Network, Toronto
Enrolment target
40
Start
20 Apr 2023
Estimated completion
31 Dec 2025

What is this study about?

Imagine you have a small lump in your thyroid gland, which is a gland in your neck that makes important hormones. Sometimes, these lumps can be cancerous, but if they're small and low-risk, doctors are always looking for better ways to treat them. This study is all about trying out a new treatment called radiofrequency ablation (RFA) for these specific types of small thyroid cancers. Think of RFA as a very precise way to use heat to treat the tiny cancerous area without needing to remove a whole part of your thyroid.

The main idea behind this study is to check if RFA is a safe and practical option for people with small thyroid cancers (2cm or less). They want to make sure it works well and that patients recover smoothly. The researchers also hope that people who have RFA will be able to go back to their daily lives quickly and won't have the common side effects that can come with traditional surgery, like an underactive thyroid. If successful, this could mean fewer people needing bigger operations for these small cancers.

The study will also look at how RFA compares to traditional surgery in terms of costs and resources. This isn't about what you personally pay, but about the bigger picture for the healthcare system. By comparing RFA expenses (like equipment and staff time) with surgery expenses (like operating room time and hospital stays), the researchers can understand if RFA is a good option not just for patients, but for the health service as well.

Key takeaways

  • This study evaluates a non-surgical treatment (RFA) for small thyroid cancers.
  • It aims to see if RFA is safe, effective, and helps patients recover well.
  • RFA uses heat to treat the cancer, potentially avoiding bigger operations.
  • Participants will have regular check-ups for at least a year after the procedure.
  • The study focuses on low-risk thyroid cancers 2cm or smaller.
  • Researchers will compare RFA costs to traditional surgery to assess its overall feasibility.

Who may be eligible?

To join this study, you need to be an adult between 18 and 100 years old. You should have a thyroid lump that is 2 centimetres or smaller, and doctors need to be very sure that it’s a low-risk thyroid cancer based on specific tests.

It’s also important that you can understand what the study involves and agree to take part in writing. You must also be able to come to all the follow-up appointments the study requires.

There are certain reasons why you wouldn't be able to join. For example, if you're under 18 or pregnant. You also can't take part if there's any concern that your thyroid cancer has spread or is very aggressive, or if you've already had treatment for thyroid cancer before.

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.

  1. Are you between 18 and 100 years old?
  2. Is your thyroid lump 2cm or smaller and confirmed as a low-risk cancer?
  3. Are you able to attend all follow-up appointments?
  4. Have you *not* had treatment for thyroid cancer before?
  5. Are you *not* pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the process will involve a few steps. First, you'll have some routine tests and scans, just like you would before any medical procedure, to get a clear picture of your thyroid lump. Then, you'll have the RFA procedure itself, which is where the doctor uses heat to treat the cancer.

After the procedure, you'll have three important follow-up appointments in the first year: at 4 weeks, 6 months, and 12 months. These appointments are really important for checking how you're doing and how the treatment worked. After the first year, you'll continue to have check-ups every 6 months until the study finishes. During these visits, doctors will check for any issues, take blood samples to measure your thyroid hormone levels, and use ultrasound to see how the thyroid lump is looking. They might also do another biopsy after 12 months just to see how the cells in the treated area have changed. You'll also be asked to fill out a questionnaire at the beginning and a few months after the RFA to share how you're feeling about your treatment and recovery.

Potential risks and benefits

Taking part in this study could offer some potential benefits, as RFA is a less invasive procedure than traditional surgery, meaning you might have a quicker recovery and avoid the need for a bigger operation. The study aims to show that patients have a good quality of life and avoid an underactive thyroid. However, like all medical procedures, RFA carries some potential risks, which will be fully explained by the study team. These could include things like pain or bruising at the treatment site, or other rare complications. You will have a clear right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

  • University Health Network
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is radiofrequency ablation (RFA)?

RFA is a method that uses heat to treat small areas of tissue, like a small cancerous lump, without needing to cut or remove it through surgery.

Why is this study focusing on small thyroid cancers?

The study is looking at small, low-risk thyroid cancers (2cm or less) because RFA might be a good alternative to traditional surgery for just these types of cancers.

Will I have to pay to be in this study?

No, you will not have to pay for the RFA treatment or any of the study-related appointments or tests if you participate.

How long will I be involved in the study?

You will have follow-up appointments for at least 12 months, and then every six months after that until the study concludes, which could be several years.

What if I change my mind after joining?

You have the right to leave the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Jesse Pasternak

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "The Safety and Feasibility of Radiofrequency Ablation to Tre…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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