Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Digoxin for the Reinduction or Radioiodine Uptake in Metastatic or Locally Advanced Non-medullary Thyroid Carcinoma.

This research trial is investigating whether a common heart medicine, called digoxin, can help improve how a special scan (radioiodine scan) works for people with a specific type of thyroid cancer. This type of cancer, called non-medullary thyroid carcinoma, has either spread to other parts of the body or is advanced locally, and has become difficult to detect with standard radioiodine scans. The study aims to see if digoxin can make the cancer cells more visible to the scan, which could potentially help guide future treatments. It's a Phase II study, meaning it's an early-stage trial testing the treatment's effectiveness and safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Stichting Radboud University Medical Center

Enrolment target

Start

23 Aug 2022

Non-medullary thyroid Carconoma (NMTC)

What is this study about?

This study is about a type of thyroid cancer called non-medullary thyroid cancer. Sometimes, this cancer can spread or grow quite large, and standard treatments might not work as well. One common treatment involves using a special form of iodine (radioiodine) that cancer cells take up. However, sometimes the cancer cells stop taking up this iodine, making it harder to treat and monitor.

Researchers are looking into whether a medicine called digoxin (which is often used for heart conditions) can help these thyroid cancer cells start taking up radioiodine again. If the cancer cells take up the radioiodine, doctors can then use radioiodine scans to see the cancer more clearly, and potentially use radioiodine therapy more effectively to treat it.

The main goal of this study is to see how many people show an improvement in their radioiodine scans after taking digoxin. They will also look at how patients feel, how the cancer responds over six months, and any side effects. This research could lead to new ways to help people with advanced thyroid cancer where current treatments are struggling.

Key takeaways

This study explores a potential new use for an existing heart medicine (digoxin) in advanced thyroid cancer.
It aims to make thyroid cancer cells more visible on special scans (radioiodine scans).
Participation involves taking digoxin and having regular scans and blood tests.
The study assesses both the potential benefits and any side effects.
All adults (18+) with specific advanced thyroid cancer types are invited to inquire.
You can stop participating in the study at any time.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old, and your gender doesn't matter – men and women can both take part.

You would be eligible if you have a specific type of thyroid cancer called non-medullary thyroid carcinoma, which has either spread to other parts of your body or is advanced locally. A key requirement is that your cancer must have previously been difficult to see on a radioiodine scan, meaning it hasn't been taking up the radioiodine very well.

The study team will carefully check other specific health details to make sure the trial is safe and suitable for you. It's important to discuss your full medical history with the study doctor.

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 non-medullary thyroid carcinoma (a type of thyroid cancer)?
Has your thyroid cancer spread or is it considered advanced?
Has your cancer previously been hard to see on a radioiodine scan (it didn't take up radioiodine well)?
Are you able to attend regular appointments and scans?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the study medication, digoxin. You would also have regular appointments, which would include special body scans (called radioiodine scintigraphy) to see if the cancer is taking up the radioiodine. These scans are a key part of monitoring how the digoxin is working.

Over a period of at least 6 months, doctors would also measure certain markers in your blood, like thyroglobulin, which can indicate how the cancer is responding. Your quality of life would be assessed using questionnaires, and they would carefully monitor any potential side effects of the treatment. The overall duration of your participation would involve these assessments for at least 6 months, and potentially follow-up beyond that.

Potential risks and benefits

Participating in this study might offer a potential benefit if digoxin helps your cancer cells take up radioiodine again, which could open up new treatment options. However, as with any medication, there are risks of side effects from digoxin. Your doctors will carefully monitor you for these. It’s important to remember that you can decide to leave 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
Netherlands

Common questions

What is non-medullary thyroid carcinoma?

It's a common type of thyroid cancer that starts in the follicular cells of the thyroid gland. This study focuses on cases where it has spread or is advanced.

What is radioiodine uptake?

This is when thyroid cells, including some cancer cells, absorb a special form of iodine. Doctors use this to find and sometimes treat thyroid cancer with scans and therapy.

What is digoxin?

Digoxin is a long-standing medicine often used to treat certain heart conditions. In this study, it's being tested for a new use in thyroid cancer.

What is a Phase II study?

Phase II studies are early trials that test if a new treatment is effective and safe for a specific condition in a larger group of people than a Phase I study.

Will I know if the treatment is working?

The study team will monitor your progress with scans and blood tests, and they will discuss the results with you throughout your participation.