RecruitingNAINTERVENTIONAL

Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors

This study is looking at a new treatment for certain types of skin cancer. It's called DaRT, which stands for Diffusing Alpha-emitters Radiation Therapy. This treatment involves placing very small radioactive seeds directly into the skin tumour. The idea is that these seeds release a special type of radiation called 'alpha radiation' right where the cancer is. We want to find out if this treatment is safe for people with skin cancer and if it helps to shrink tumours. This study will follow participants over time to check how well the treatment works and if there are any side effects. It's a new approach that combines the idea of focused radiation therapy with a powerful, targeted type of radiation.

At a glance

Status

Recruiting

Phase

Sponsor

Alpha Tau Medical LTD.

Enrolment target

Start

01 Apr 2022

Estimated completion

01 Jan 2025

Skin Cancer Cutaneous Tumor Cutaneous Metastasis

What is this study about?

This study is exploring a new way to treat certain skin cancers using a special technique called Diffusing Alpha-emitters Radiation Therapy, or DaRT. Imagine tiny, pin-like devices, called 'seeds,' that are carefully placed directly into the skin tumour. These seeds release a very specific type of radiation, called alpha radiation, which is designed to attack the cancer cells in the tumour. The goal is to deliver this radiation only where it's needed, aiming to destroy the cancer cells while limiting harm to healthy tissues nearby.

This method is a bit like a focused attack, using a small amount of powerful radiation directly at the problem area. Researchers want to see if this precise way of treating skin tumours is both safe and effective. They will be looking closely at how much the tumours shrink and if participants experience any side effects. This study is important because it could offer a new option for people with certain types of skin cancer.

The study is designed to be carefully monitored. It's an 'open-label' study, meaning both you and your doctors will know you are receiving the DaRT treatment. It's also 'multi-centre,' so it's happening in several locations, which helps gather more information. The main things being checked are whether the tumours get smaller after 9-11 weeks and if any side effects occur. The amount of radiation used in DaRT is generally much lower than in some other radiation treatments, which is another area of interest for researchers.

Key takeaways

This study is testing a new way to treat certain skin cancers using small radioactive seeds.
The treatment involves placing 'DaRT' seeds directly into the tumour to deliver targeted radiation.
The main aims are to see if the treatment is safe and if it helps to shrink the tumours.
You would need to have specific types of skin cancer and meet certain health criteria to join.
Participation involves having the seeds inserted and then regular follow-up checks.
You can stop taking part in the study at any point if you wish.

Who may be eligible?

This study is for adults aged 18 and over who have been diagnosed with certain types of skin cancer, specifically Squamous Cell Carcinoma (SCC), Basal Cell Carcinoma (BCC), a type of melanoma called Lentigo Maligna, or Carcinosarcoma. Your tumour needs to be on your skin (like on your face, scalp, arms, body), lips, or eyelids, and be no larger than 7 centimetres across. The doctors also need to confirm that the DaRT seeds can be placed effectively to cover the whole tumour.

There are also some important health checks to make sure this study is safe for you. For example, your general health should be good, and you shouldn't have other serious medical conditions that might interfere with the study. Your blood tests, especially for your blood clotting, need to be within a healthy range. If you are a woman who could become pregnant, you would need to have a negative pregnancy test. You also can't be pregnant or breastfeeding during the study.

Some conditions would prevent you from joining. For instance, if your skin cancer has spread to other parts of your body (metastatic disease), this study wouldn't be suitable. People with certain other types of skin cancer, like Keratoacanthoma or Merkel cell carcinoma, or other types of sarcomas, also can't participate. If you are taking medicines that suppress your immune system (unless it's just short-term use of steroids), or if you've been in another similar study recently, you might not be able to join.

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 Squamous Cell Carcinoma (SCC), Basal Cell Carcinoma (BCC), Lentigo Maligna, or Carcinosarcoma?
Is your tumour on your skin, lips, or eyelids, and no larger than 7cm?
Has your cancer not spread to other parts of your body?
Are you generally in good health with no major immune system conditions?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a number of checks to make sure you are suitable. Once confirmed, the DaRT seeds will be carefully inserted into your skin tumour. This procedure will be explained to you in detail.

After the seeds are in place, you will have follow-up appointments. The main assessment of how well the treatment is working will happen about 9 to 11 weeks after the seeds are inserted. During these appointments, doctors will measure your tumour to see if it has shrunk. They will also talk to you about your general health and record any side effects you might be experiencing. The study will continue for a certain period, and you'll have regular checks throughout to monitor your progress and safety. The full duration of your participation, including all follow-ups, will be clearly explained before you agree to join.

Potential risks and benefits

Participating in this study might offer a potential benefit if the DaRT treatment is effective in shrinking your skin cancer, which is the main goal of the research. However, as with any medical treatment, there are potential risks and side effects. These could include irritation or pain at the site where the seeds are inserted, or other less common reactions to the radiation. The study doctors will carefully monitor you for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

CHU Grenoble Alpes
Verified postcode
Grenoble, France· Recruiting
Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting

Common questions

What is 'alpha radiation'?

Alpha radiation is a type of energy released by radioactive materials. In this study, it's used in a very targeted way within tiny seeds placed directly into the tumour to destroy cancer cells.

Will the treatment be painful?

The process of inserting the seeds will involve a local anaesthetic to numb the area, similar to other minor procedures. You will be monitored for any discomfort afterwards.

How long will the seeds stay in my body?

The detailed plan for the seeds, including how long they remain active or if they are removed, will be explained by the study team. It's designed to deliver the radiation effectively.

What kind of follow-up will I need?

You'll have regular hospital visits, including physical examinations and measurements of your tumour, to see how the treatment is working and to check for any side effects.

Is this a new type of treatment?

Yes, DaRT is a relatively new approach to delivering radiation directly into tumours, specifically using alpha radiation emitters.

How to find out more

Liron Dimnik

lirond@alphatau.com +972-2-373-7000 Official trial record

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