RecruitingNAINTERVENTIONAL

Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC

This study is looking into a new treatment called YntraDose™ for pancreatic cancer that has spread too much to be surgically removed. The treatment involves a doctor injecting a tiny radioactive implant directly into the pancreatic tumour once. This will be given alongside your usual chemotherapy. The main aims are to see how safe and manageable this new treatment is, whether it's practical to give, and how it affects your quality of life, including pain. Researchers will also monitor how the tumour responds over three months. This is an early study, so it will involve a small number of patients.

At a glance

Status

Recruiting

Phase

Sponsor

BetaGlue Therapeutics SpA

Enrolment target

Start

03 Feb 2026

Estimated completion

01 Feb 2027

Pancreatic Ductal Adenocarcinoma (PDAC)Locally Advanced Unresectable

What is this study about?

This clinical study is exploring an innovative approach to treating locally advanced pancreatic cancer that can't be removed with surgery. This type of cancer is often challenging to treat, so doctors are always looking for new ways to help patients. The treatment being tested, called YntraDose™, is a new form of targeted radiotherapy. It involves a doctor carefully injecting a special device containing tiny radioactive particles directly into the pancreatic tumour. This is designed to deliver radiation precisely to the cancer cells, aiming to shrink the tumour and reduce its growth, while minimising damage to healthy surrounding tissues.

The study aims to understand several key things. Firstly, it wants to know if this new treatment is safe when combined with the standard chemotherapy you would already be receiving. Secondly, it's important to find out if it's practical and straightforward for doctors to administer this injection directly into the pancreas. Researchers will also closely monitor how the treatment affects your overall well-being, including any changes in pain levels and your general quality of life. Finally, they will observe how the pancreatic tumour responds to the treatment over a three-month period after the injection.

The hope is that by combining this precise, targeted radiotherapy with standard chemotherapy, it might offer a more effective way to control the cancer, potentially improving symptoms and, in some cases, even making the tumour small enough for surgery later on. This is an early stage study, meaning it's one of the first times this treatment is being used in patients, so the focus is on gathering important information about its safety and how it works.

Key takeaways

This study explores a new targeted radiation treatment for advanced pancreatic cancer.
It involves a single injection of radioactive particles directly into the tumour.
The new treatment is given alongside standard chemotherapy.
Researchers will assess safety, how practical the treatment is, and its impact on quality of life.
Participation involves about 7 months, with regular clinic visits and careful monitoring.
This is an early stage study, carefully designed to gather important information.

Who may be eligible?

To be considered for this study, you would typically have pancreatic cancer that has been confirmed by a doctor and is considered 'locally advanced', meaning it hasn't spread to distant parts of the body and can't be surgically removed at this stage.

Key health requirements include having generally good health and being well enough to receive standard chemotherapy. This means your blood counts, and your liver and kidney functions need to be within acceptable ranges. The tumour itself needs to be a certain size and you shouldn't have received radiation therapy for your pancreatic cancer before.

There are also reasons why you might not be able to join. For example, if your scans show that the cancer has spread to other parts of your body, or if your health isn't strong enough. Other reasons include certain blood clotting issues, active infections, severe organ problems, or other serious health conditions that could make the treatment or anaesthesia risky.

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.

Have you been diagnosed with pancreatic cancer that is locally advanced and cannot be surgically removed?
Do you have generally good health and are you well enough to receive chemotherapy?
Have you not had radiation treatment for your pancreatic cancer before?
Is your tumour confirmed to be within specific size limits?
Are you able to manage regular clinic visits and follow-up appointments?
Do you have no evidence of the cancer having spread to distant parts of your body?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved for about 7 months in total. Throughout this time, you will continue to receive your standard chemotherapy treatment.

Initially, you'll have standard chemotherapy for about two months. This will then be paused briefly so doctors can review your tumour. After this, your chemotherapy will restart, and you will receive the new YntraDose™ treatment. This involves a single injection of the radioactive implant directly into your pancreatic tumour. You will stay in hospital for 2 nights and 3 days for this procedure and for close monitoring. Following this, you will continue with your standard chemotherapy.

Over the next three months, you will have several follow-up visits. In total, you'll visit the clinic 8 times. During your participation, you will complete questionnaires to help researchers understand how the treatment is affecting your daily life and pain levels. You will also have various scans, such as CT and MRI, and blood and urine samples will be taken to check your safety and how you're responding to the treatment.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new treatment that could help control your pancreatic cancer and improve your quality of life. However, like all medical treatments, there are potential risks, including side effects from the injection or the radiation. You will be closely monitored for any issues. It's important to remember that this is a research study, and we don't yet know if the new treatment will be effective or if it will have side effects that haven't been fully identified. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

Fondazione Policlinico Universitario A. Gemelli, IRCCS
Verified postcode
Roma, Italy· Recruiting
Guy's & St Thomas' and Kings College Hospitals
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is pancreatic cancer?

Pancreatic cancer starts in the pancreas, an organ located behind the stomach that helps with digestion and making hormones. 'Locally advanced' means it has grown into nearby tissues but hasn't spread to distant parts of the body.

What is YntraDose™?

YntraDose™ is a new type of treatment involving tiny radioactive particles that are injected directly into your pancreatic tumour. It's designed to deliver targeted radiation to cancer cells.

Will I still get my regular chemotherapy?

Yes, you will continue to receive your standard chemotherapy treatment throughout the study period, with a brief pause for the new treatment to be given.

How long will I be in the study?

Your participation in the study will last for approximately 7 months in total.

What if I change my mind about participating?

You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Carol Hegarty, PhD

c.hegarty@betaglue.com +44 7752 303229 Official trial record

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