RecruitingNAINTERVENTIONAL

A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

This study is testing a new way to treat squamous cell carcinoma, a kind of skin cancer, when it has returned. The treatment, called Alpha DaRT224, uses small 'seeds' that give off radiation directly into the tumour. Doctors want to see how much the tumours shrink after this treatment and for how long. They also want to understand any side effects. This study is for people whose cancer has come back and who can’t have surgery or standard radiation. The goal is to find out if this new treatment is both effective and safe for patients who have limited choices.

At a glance

Status

Recruiting

Phase

Sponsor

Alpha Tau Medical LTD.

Enrolment target

Start

21 Sep 2022

Estimated completion

01 Dec 2025

Recurrent Squamous Cell Carcinoma

What is this study about?

This study is looking at a new treatment called Alpha DaRT224 for a type of skin cancer known as squamous cell carcinoma, especially when the cancer has returned after previous treatments. For some people, surgery or standard radiation therapy might not be suitable, or there might not be other effective treatments available. This research aims to offer a new option for these patients.

Alpha DaRT224 works by placing tiny 'seeds' directly into the cancer tumour. These seeds release small amounts of radiation that are designed to target and destroy the cancer cells nearby. After about 2 to 3 weeks, these seeds are carefully removed. The study will track how well the tumours respond, meaning if they shrink or disappear, and how long these effects last. Researchers will also closely monitor patients for any side effects to make sure the treatment is safe.

The main goal is to understand if Alpha DaRT224 can effectively shrink tumours and improve the quality of life for patients. The study also looks at how long patients live without their cancer getting worse and their overall survival. This is an important step in finding new and better ways to treat recurrent squamous cell carcinoma, particularly for those who have tried other treatments without success.

Key takeaways

This study evaluates a new radiation treatment (Alpha DaRT224) for recurrent skin cancer.
It targets squamous cell carcinoma when other treatments are not an option.
Small radioactive seeds are placed directly into the tumour for a few weeks.
The study measures how much tumours shrink and for how long, as well as safety.
It aims to offer a new treatment choice for patients with limited options.

Who may be eligible?

This study is looking for adults aged 18 or over. To be considered, you must have squamous cell carcinoma that has come back, and your doctors must have confirmed it with a tissue sample (biopsy) in the last six months. It's important that your cancer can’t be treated with surgery or standard radiation and that there are no other good treatment options currently available for you.

Your tumour needs to be a certain size (no bigger than 7cm across) and you should ideally have only one affected area. Doctors will check to make sure the Alpha DaRT seeds can be safely placed in and removed from your tumour without affecting important body parts like major blood vessels or bones. You'll also need to be well enough to take part, meaning you can carry out most of your usual daily activities without too much help.

There are also some blood test results and other health checks needed to make sure the treatment is safe for you. If you are a woman who could become pregnant, or a man whose partner could, you’ll need to use reliable birth control during and for a short time after the study. Women must also have a negative pregnancy test before starting. Your healthcare team will discuss all these points with you in detail.

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.

Is my squamous cell carcinoma recurrent (has come back)?
Have I been told that surgery or standard radiation isn't suitable for me?
Do I have only one tumour that's no bigger than 7cm?
Am I generally well enough to do most of my daily activities?
Am I willing to use contraception if I need to?

Answer every question to see your result.

What does participation involve?

If you join this study, doctors will insert tiny Alpha DaRT seeds directly into your cancer tumour. These seeds stay in for about 2 to 3 weeks (14 to 21 days), after which they will be carefully removed. Throughout the study, you will have regular check-ups and scans, like CT scans, to see how the tumour is responding and to monitor your general health. You'll also have blood tests at certain times.

The study team will ask you questions about your well-being and any side effects you might experience. This helps them understand the treatment's safety and how it affects your daily life. You'll be followed up for a good amount of time after the treatment to see how long its effects last and to keep an eye on your overall health. The total time you're involved in the study will vary, but it's designed to give a full picture of the treatment's impact.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment option for your recurrent squamous cell carcinoma, especially if other treatments haven't worked or aren't suitable. This might lead to your tumour shrinking or disappearing, which could improve your quality of life. However, as with any medical treatment, there are potential risks and side effects that could occur from the insertion of the seeds, the radiation they emit, or the procedure itself. These will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (30)

Banner Health MD Anderson Phoenix
Verified postcode
Gilbert, United States· Recruiting
Dignity Health Cancer Institute
Verified postcode
Phoenix, United States· Completed
Alliance Dermatology
Verified postcode
Phoenix, United States· Recruiting
UCLA
Verified postcode
Los Angeles, United States· Recruiting
Day Star Skin and Cancer Center
Verified postcode
DeLand, United States· Recruiting
Integrity Research Clinical Associates
Verified postcode
Delray Beach, United States· Recruiting
Palm beach Dermatology Group
Verified postcode
Delray Beach, United States· Recruiting
Hollywood Dermatology
Verified postcode
Hollywood, United States· Recruiting
University of Miami
Verified postcode
Miami, United States· Recruiting
Baptist Health South Florida MCI
Verified postcode
Miami, United States· Recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Completed
Beer Dermatology
Verified postcode
West Palm Beach, United States· Recruiting

Common questions

What is squamous cell carcinoma?

It's a common type of skin cancer that starts in the flat cells on the surface of your skin.

What is Alpha DaRT224?

It's a new treatment that places small radioactive 'seeds' directly into a tumour to destroy cancer cells.

How long do the seeds stay in?

The seeds typically stay in the tumour for about 2 to 3 weeks (14 to 21 days) before being removed.

Will I have to make a lot of hospital visits?

You will have several visits for the treatment itself, check-ups, scans, and blood tests to monitor your health and the tumour's response.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, and it won't affect your future medical care.

How to find out more

Liron Dimnik

lirond@alphatau.com +972-2-3737-210 Official trial record

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