Active not recruitingNAINTERVENTIONAL

Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer

This study is looking into a new way to treat advanced pancreatic cancer that can't be cured by surgery. It uses tiny devices, called Alpha DaRT seeds, that are placed directly into the tumour. These seeds release a special type of radiation (alpha radiation) to attack the cancer cells. Researchers want to find out if this treatment is safe and if it can help shrink tumours or slow down the cancer's growth. They will also be checking how well people tolerate the treatment. The study will involve around 30 patients and will monitor them carefully for about two years after the treatment is given to see how they get on. This is an early-stage study to learn more about this promising new approach.

At a glance

Status

Active not recruiting

Phase

Sponsor

Alpha Tau Medical LTD.

Enrolment target

Start

20 Oct 2020

Estimated completion

01 Oct 2026

Pancreatic Cancer Unresectable Pancreatic Cancer Metastatic Pancreatic Cancer Pancreatic Adenocarcinoma

What is this study about?

Pancreatic cancer can be a very challenging disease, especially when it's advanced or has spread, meaning surgery isn't an option. Doctors are always searching for new and better ways to treat it. This study is exploring a very new and unique approach called Diffusing Alpha Radiation Emitters Therapy, or DaRT for short.

The main idea behind DaRT is to deliver radiation directly into the cancer cells. Instead of external radiation beams that pass through the body, tiny devices called "seeds" are carefully placed inside the tumour. These seeds then release a special kind of radiation called alpha radiation, which is designed to harm the cancer cells while trying to limit damage to healthy tissues nearby. The hope is that this targeted approach could be more effective or have fewer side effects than current treatments.

This study is one of the first times this specific DaRT treatment is being used for advanced pancreatic cancer. Researchers are keen to see if it's a practical and safe treatment option, and if it shows any early signs of helping patients. It's a single-centre study, meaning it's happening at one hospital, and it will involve about 30 patients. The results of studies like this help doctors understand if a new treatment is worth exploring further in larger trials.

Key takeaways

This is an early-stage study testing a new form of radiation treatment (DaRT) for advanced pancreatic cancer.
Small radioactive seeds are placed directly into the tumour to deliver targeted radiation.
It's for people whose pancreatic cancer cannot be removed by surgery.
The study aims to see if the treatment is safe and if it shows early signs of effectiveness.
Participation involves monitoring for up to two years after the treatment procedure.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) with pancreatic cancer that has been confirmed by a biopsy. Your cancer needs to be considered advanced – either locally advanced (Stage II or III) or metastatic (Stage IV) – and it must be clear that surgery is not a suitable option for you, for reasons like the cancer having spread, or doctors feeling it's too risky for you to have surgery.

Also, a specific tumour in your pancreas or nearby lymph nodes needs to be no larger than 4cm in its longest measurement. You should generally be well enough to take part, with a life expectancy of at least 12 weeks. If you are able to become pregnant, you would need to have a negative pregnancy test. You also need to be willing to read and sign a consent form, showing you understand what taking part involves.

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.

Do you have pancreatic cancer confirmed by biopsy?
Has your doctor told you your pancreatic cancer is advanced and cannot be surgically removed?
Is your specific tumour (or nearby lymph node) no bigger than 4cm?
Are you 18 years old or older?
Are you generally well enough to take part and expected to live at least 12 weeks?
Have you not had radiation therapy to your stomach area before?

Answer every question to see your result.

What does participation involve?

If you are interested and considered eligible, you would first have a screening period to check all the criteria. If you qualify, you'd come to the hospital for the procedure where the DaRT seeds are carefully placed into your tumour. This is the main treatment step. After this, you'll have close check-ups for about 4 to 6 weeks, which is called the acute follow-up phase, to make sure you're recovering well and to check for any immediate side effects.

After this initial period, you would enter a longer follow-up phase which lasts for about 24 months (two years). During this time, you would have regular appointments, scans, and tests to monitor your health, how the treatment is working, and to check for any long-term effects. The total time you would be involved in the study, from your DaRT insertion procedure to your final check-up, would be around two years.

Potential risks and benefits

As this is a new treatment, the potential benefits are not fully known, but researchers hope it might help control advanced pancreatic cancer for people who have limited treatment options. However, as with any medical procedure, there are potential risks, including side effects from the radiation or the seed insertion procedure itself. The research team will explain all known and potential risks in detail. You are free to withdraw from the study at any time, for any reason, and this decision will not affect your future medical care.

Locations (2)

Centre Hospitalier de l'Université de Montréal (CHUM)
Verified postcode
Montreal, Canada
Jewish General Hospital
Verified postcode
Montreal, Canada

Common questions

What is 'advanced pancreatic cancer' in this study?

It means the cancer is either locally advanced (Stage II or III) or has spread to other parts of the body (Stage IV), and surgery to remove it isn't possible.

What are Alpha DaRT seeds?

These are small devices placed directly into the tumour that release a specific type of radiation, called alpha radiation, to target and destroy cancer cells.

How long will I be involved in the study?

After the DaRT seeds are put in, you'll be monitored closely for 4-6 weeks, then have regular check-ups for a total of two years.

Can I have other cancer treatments at the same time?

No, you cannot be having chemotherapy or immunotherapy at the same time as this study's treatment, nor have had abdominal radiation in the past.

Is this treatment guaranteed to work?

No, as this is an early-stage study, we don't know yet if it will work. The study aims to find out if it's safe and shows any signs of benefit.