At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas (device)
- How long the study runs
- Study runs about 12 months (dates as stated)
- About the drug or intervention
- Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas — device: YntraDose™ is a locoregional therapy device used for percutaneous radio-ablation of solid tumours
- Patient visit burden
- Not specified by the sponsor
In plain English
This early-stage study is looking at YntraDose™ as an extra (neoadjuvant) treatment given before other therapy for people with locally advanced pancreatic ductal adenocarcinoma (PDAC) that cannot be removed by surgery. Sponsored by BetaGlue Therapeutics SpA, it is testing whether this treatment is feasible and safe to use in this group of patients.
Who can take part
- Confirmed pancreatic adenocarcinoma from a tissue or cell sample
- Disease is locally advanced and cannot be removed by surgery
- No previous radiotherapy for pancreatic cancer
- Tumour is at least 2.6 cm across and between 9 and 34 ml in volume
- Fully active or only mildly restricted in daily activities (performance status 0 or 1)
- Blood, liver and kidney results good enough for standard chemotherapy
- Expected to live at least 6 more months
Who may not be able to
- Cancer has spread to other parts of the body, shown on scans after two months of chemotherapy
- The tumour has changed from being unable to be removed to being removable after two months of chemotherapy
- More than one tumour, if one of them cannot be treated with YntraDose™ for medical reasons
- Performance status worse than 1
- Any cancer in the last 3 years
- Blood clotting problems that could cause bleeding during the procedure
- An active infection, such as peritonitis or an abscess
- Severe failure of the liver, kidneys or heart
- Heart or other conditions that make anaesthesia unsafe
- Pancreatitis (acute or a flare-up of long-term inflammation)
What taking part involves
- • YntraDose™ given as a neoadjuvant treatment, meaning before or alongside other planned therapy
- • The treatment involves an organ puncture (a needle procedure) to deliver it
- • Standard of care chemotherapy, as given in normal local practice
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 10
- Started
- 2026-02-03
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for pancreatic ductal adenocarcinoma (pdac)
- • NA - 10 participants
- • The goal of this clinical investigation is to learn if a new type of radiotherapy works to treat pancreatic cancer that cannot be removed surgically
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with pancreatic ductal adenocarcinoma (pdac)
Where?
- • London - Guy's & St Thomas' and Kings College Hospitals
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this clinical investigation is to learn if a new type of radiotherapy works to treat pancreatic cancer that cannot be removed surgically. It will also learn about the safety of the new treatment when combined with chemotherapy. The treatment involves injecting a radioactive implant (medical device) directly into the pancreatic tumour on one occasion only. The main questions it aims to answer are: * Is the new treatment safe and tolerable when used in combination with standard of care chemotherapy. * Is it feasible to inject the new treatment directly into a patient's pancreatic tumour. * What is the impact of this new treatment on a patient's quality of life including a pain evaluation. * To assess how the pancreatic tumour responds to the treatment during the 3 month follow up. Participants will: * Participate in the research study for approximately 7 months and will receive standard of care chemotherapy throughout their participation. * Participants will initially receive standard of care chemotherapy which will be stopped after 2 months to reassess the tumor by a multidisciplinary tumor board. Chemotherapy will resume and the test device will be administered between chemotherapy treatments. The new treatment involves a single injection of the radioactive implant directly into the pancreatic tumour. Following treatment, the participant's standard of care chemotherapy will resume. * Participants will attend follow up visits over 3 months. * Participants will visit the clinic on 8 separate occasions and on one occasions, will remain in hospital for 2 nights/3 days to receive treatment with the new radiotherapy device and to monitor for safety. * Participants will complete questionnaires to check how the treatment is affecting their daily lives and pain levels. * Participants will undergo different types of imaging (scans) such as CT, MRI. * Participants will have bloods and urine taken to monitor safety.
More detail
The study is a multicentre, open-label, prospective, early feasibility clinical investigation to assess the safety, tolerability and feasibility of YntraDose™ treatment following percutaneous administration under Ultrasound/CT guidance. The investigational device is YntraDose™, which is a locoregional therapy device used for percutaneous radio-ablation of solid tumours delivering targeted radiation using Y-90 microspheres injected directly into the tumour site, within a glue matrix holding the Y-90 microspheres in place. The product is designed for single use. YntraDose™ is indicated as a neoadjuvant therapy and add-on treatment to first-line standard of care therapy in patients with unresectable LA-PDAC. The aim of YntraDose™ development is to combine it with chemotherapy standard of care (FOLFIRINOX or gemcitabine/nab-paclitaxel). Combining systemic chemotherapy with radiotherapy for local disease control, may improve time to progression of local disease, pain control, performance status, and quality of survival, and in a neoadjuvant setting may convert tumours to resectability. YntraDose™ will be administered intratumorally and percutaneously into the pancreas under ultrasound/CT guidance. The Y-90 microspheres have been designed to deliver a localized distribution of beta radiation within the target tumour. The radiation from these particles causes direct damage to cancer cell DNA, which renders them incapable of further cell division and proliferation, leading to tumour shrinkage. The glue matrix is a hydrogel that polymerizes in the site of implantation and serves to retain the Y 90 radioactive microspheres in-situ facilitating the effect of radioactive microspheres in the tumoural tissue only. Ten (10) patients with unresectable locally advanced pancreatic ductal adenocarcinoma meeting the eligibility criteria will be recruited into the clinical investigation.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Inclusion Criteria (Main):
- ✓Histologically or cytologically proven Pancreatic Adenocarcinoma.
- ✓Stage of disease defined as unresectable that has grown locally Pancreatic Cancer.
- ✓No prior radiotherapy for pancreatic cancer.
- ✓Target tumour with a minimum diameter of 2.6 cm and a volume of from 9 to 34 ml.
See the full criteria
Where Is This Study? (1 UK site)
Guy's & St Thomas' and Kings College Hospitals
London, United Kingdom
How to Get in Touch
Carol Hegarty, PhD
Sponsor contactCONTACT