Not yet recruitingNot ApplicableInterventional

A study of diffusing alpha-emitters radiation therapy for the treatment of different cancer types

Standard cancer treatments like surgery, chemotherapy, or external radiotherapy do not always work well, especially if a cancer returns or sits near delicate organs. This UK clinical trial is testing a new internal radiation treatment called DaRT (Diffusing Alpha-emitters Radiation Therapy). DaRT works by placing tiny, specially coated metal tubes straight into a tumour. These tubes release powerful, short-range radiation particles called alpha particles. Because these particles travel only a tiny distance, they attack cancer cells from the inside without causing heavy damage to nearby healthy organs. The study is open to adults with biopsy-confirmed solid tumours that doctors can safely reach. Participants have the implants placed and either removed after two weeks or left safely in place. Researchers will monitor participants for six months using scans and check-ups to assess tumour shrinkage, side effects, and overall quality of life.

At a glance

Status

Not yet recruiting

Phase

Not Applicable

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

Start

02 Mar 2027

Estimated completion

01 Mar 2031

Solid tumours

What is this study about?

Standard cancer treatments such as surgery, chemotherapy, and traditional radiotherapy are widely used, but some cancers can be difficult to treat. Tumours that come back after earlier treatment or sit very close to vital organs can be especially challenging to treat safely with standard external radiation beams, which must pass through healthy skin and tissue to reach the cancer.

To tackle this problem, researchers at Cambridge University Hospitals NHS Foundation Trust are testing an innovative treatment called DaRT (short for Diffusing Alpha-emitters Radiation Therapy). Instead of aiming radiation at the body from the outside, doctors insert tiny hollow metal tubes directly inside the tumour using special applicators.

These tubes are coated with a mild radioactive material that releases alpha radiation. Alpha particles are very effective at breaking down cancer cells, but they only travel microscopic distances. This means they deliver high-energy treatment straight into the tumour while sparing the surrounding healthy organs from harm.

By testing DaRT across different types of solid tumours, doctors hope to find out if this method can shrink tumours, stop cancer growth, and cause fewer side effects than standard treatments. If successful, DaRT could offer a helpful new treatment option for people living with hard-to-treat cancers.

Key takeaways

This UK trial tests DaRT, an internal radiotherapy that attacks solid tumours from the inside.
Tiny radioactive tubes are placed directly into the cancer to spare surrounding healthy tissue.
The treatment is aimed at adult patients whose tumours can be safely reached by doctors.
The study is based at Cambridge University Hospitals NHS Foundation Trust.
Participants will be monitored closely for six months with scans, blood tests, and check-ups.

Who may be eligible?

This study is open to adults aged 18 and over who have a solid cancer confirmed by a biopsy. It is designed for people with newly diagnosed cancer or cancer that has returned or spread, provided an NHS cancer specialist team agrees the treatment is suitable. Importantly, the tumour must be in an area that doctors can safely reach to insert the DaRT tubes.

You may be able to join whether you have had previous radiotherapy or not, though there must be a break of at least 30 days since your last chemotherapy, targeted therapy, or radiation to that specific area. You also need to be reasonably active and able to look after yourself in daily life.

You will not be able to take part if you are pregnant, breastfeeding, or unable to use reliable contraception during the study. You may also be excluded if you have serious underlying health conditions, bleeding problems that make minor procedures unsafe, or if you are receiving active treatment for another progressive cancer.

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.

I am aged 18 or older.
I have a solid tumour confirmed by a tissue biopsy.
My tumour is in a location that doctors can safely reach for a minor procedure.
It has been at least 30 days since my last chemotherapy, targeted therapy, or local radiation.
I am able to walk around and manage my own personal care.
I am not pregnant or breastfeeding.

Answer every question to see your result.

What does participation involve?

Taking part begins with screening checks, including scans and blood tests, to ensure the trial is safe and appropriate for you. If eligible, you will have a minor procedure where doctors insert the tiny DaRT tubes directly into your tumour. Depending on where the tumour is located, the tubes will either be gently taken out after 14 days or left permanently inside your body, where their radiation will naturally fade away. After the implant, you will attend regular hospital appointments over a six-month follow-up period. These visits will include physical health checks, imaging scans to measure your tumour, routine blood tests, and simple questionnaires about your daily wellbeing and quality of life.

Potential risks and benefits

The main hope of this study is that DaRT will control or shrink tumours with fewer whole-body side effects than conventional treatments, though direct benefits cannot be guaranteed. Because the radiation is targeted inside the tumour, most side effects happen around the treated spot. These can include local pain, swelling, bruising, mild bleeding, or infection from the tube insertion. Your care team will monitor you closely to manage any discomfort. Joining the trial is entirely voluntary, and you are free to leave at any time without your standard NHS medical care or rights being affected.

Locations (3)

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

Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England
Leeds Teaching Hospitals NHS Trust
City only
Leeds, England
Liverpool University Hospitals NHS Foundation Trust
City only
Liverpool, England

Common questions

What makes DaRT different from standard radiotherapy?

Standard radiotherapy beams radiation from an outside machine through healthy skin to reach the cancer. DaRT places tiny sources directly inside the tumour, attacking cancer cells from within and protecting nearby organs.

Will I be radioactive to my family or friends?

The alpha radiation travels only a fraction of a millimetre, staying trapped inside the tumour tissue. Your medical team will give you clear safety guidance, but DaRT does not usually stop you from safely spending time with loved ones.

Is the insertion procedure painful?

The procedure is carried out with anaesthetic to keep you comfortable. You may feel some tenderness, swelling, or bruising around the area for a few days afterwards, which can usually be managed with standard pain relief.

Do the DaRT tubes have to be removed?

Doctors will remove the tubes after 14 days if it can be done simply and comfortably. If removing them is difficult, they can be left safely inside the body, where the radioactive coating quickly becomes inactive.

Will I have to pay for the treatment?

No, all study-related treatments, medical devices, scans, and extra tests are provided free of charge through the NHS and the study sponsor.

How to find out more

Giovanni Di Stefano

giovanni.distefano1@nhs.net +44 (0)1223 348083 Official trial record

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