Pancreatic Ductal Adenocarcinoma (PDAC)NCT07155850
Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC
A study testing Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Locally Advanced, run by BetaGlue Therapeutics SpA at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC), Locally Advanced, Unresectable
- What is being tested?
- Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Feb 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven Pancreatic Adenocarcinoma.
- Stage of disease defined as unresectable Locally Advanced 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patient has acceptable hematological parameters including white and red blood counts, liver and renal function that makes them suitable to receive SoC chemotherapy as per local clinical practice.
- Life expectancy of ≥6 months at screening.
Who cannot join
- Evidence of distant metastases based on the restaging process after two months of induction chemotherapy identified using CT/MRI/18 FDG PET assessment.
- Evidence of switch from unresectable status to resectable status of disease after two months of induction chemotherapy.
- More than one primary lesion, if one of the primary lesions is not a good candidate for debulking with YntraDose™, due to clinical reasons and/or decision made by the local MDTB.
- ECOG is higher than 1.
- History of malignancy in the last 3 years.
- Blood clotting disorders (INR > 1.5, PLT < 50,000/µl - risk of bleeding during organ puncture).
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- Active systemic or local infection (e.g. peritonitis, abscess).
- Severe organ failure (e.g. end-stage liver, kidney, heart failure).
- Cardiological and other diseases that threaten the use of anesthesia.
- Pancreatitis (acute or exacerbation of chronic inflammation).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Roma
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's & St Thomas' and Kings College Hospitals
London
About this study
Official title: Early Feasibility Clinical Investigation Using a Novel 90-Yttrium-based Internal Radiotherapy Platform, YntraDose™ in Unresectable Locally Advanced Pancreatic Adenocarcinoma (LA-PDAC) as an add-on Therapy to First-line SOC (Chemotherapy)
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas
- Keywords
- LA-PDAC, Yttrium-90, YntraDose™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreasDevice
YntraDose™ is a locoregional therapy device used for percutaneous radio-ablation of solid tumours
| Study group | Role | What they receive |
|---|---|---|
| YntraDose™ implantation | Experimental | YntraDose™ is a single use radiotherapy medical device containing Yttrium-90 microspheres administered intratumourally and percutaneously into the pancreas Receives: Device: Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessment
The primary endpoint is safety and tolerability and will be measured by the frequency of treatment-emergent adverse events (TEAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v5.0).
Measured: From commencement of induction chemotherapy (immediately following screening) to the end of the follow up period at 3 months.
Feasibility of administration of the medical device
To evaluate the feasibility of YntraDose™ percutaneous administration under US/CT guidance for implant in the target tumour lesion, without major clinical complications defined as needing medical intervention to resolve any significant adverse event or medical issue arising from the administration of YntraDose™.
Measured: From implantation of the medical device to the end of the follow up period at 3 months.
Secondary outcomes (4)
Patient Quality of Life
To evaluate the patient's quality of life using the EORTC QLQPAN26 assessment questionnaire, for people with pancreatic ductal adenocarcinoma (PDAC).
Measured: From enrollment to the end of the follow up period at 3 months.
Pain Assessment
Pain will be assessed using a 11-point NPRS (Numerical Pain Rating Scale). collected at screening and during the follow up period.
Measured: Pain assessments will be collected during the 2 pre-implantation screening visits and at 1 week, 1 month, 2 months and 3 months following implantation of the investigational device.
Patient tumour response following treatment with the medical device
To evaluate the change in the tumour marker carbohydrate antigen (CA) 19-9 levels comparing baseline levels to the (CA) 19-9 levels at follow up.
Measured: From baseline assessments to the end of the follow up period at 3 months.
Metabolic tumour response evaluation
Metabolic tumour response according to [18F]2-fluoro-2-deoxy-Dglucose positron emission tomography (18F-FDG-PET) will be measured at baseline and subsequent follow-up time points, for total lesion glycolysis (TLG), standardised uptake values SUVMax and SULMax, target tumour volume change as imaged by CT scans.
Measured: From baseline to the to the end of the follow up period at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start3 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicentre, open-label, prospective, early feasibility clinical investigation to assess the safety, tolerability and feasibility of YntraDose™ treatment following percutaneous administration under US/CT guidance.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BetaGlue Therapeutics SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155850
- Sponsor's protocol ID
- CIP-PDAC-25-01
- Status last verified
- Feb 2026
- First submitted
- 1 Aug 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A Clinical Investigation Report will be prepared according to ISO 14155:2020 (Annex D) and UNI EN ISO 14155:2025. The report will be a record of the investigation conduct and findings and will be subject to approval by the Investigators who will sign the final report. Patient data will be analyzed collectively in accordance with the investigation Statistical Analysis Plan. Individual patients will not be identified in any report, presentation or publication resulting from the study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Clinical Investigation Using a Novel 90-Yttrium-based Internal Radiotherapy Platform, YntraDose™ in Unresectable Locally Advanced Pancreatic Adenocarcinoma (LA-PDAC) as an add-on Therapy to First-line SOC (Chemotherapy)
- ClinicalTrials.gov ID
- NCT07155850
- Acronym / sponsor ID
- CIP-PDAC-25-01
- Keywords
- LA-PDAC, Yttrium-90, YntraDose™
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- BetaGlue Therapeutics SpAIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicentre, open-label, prospective, early feasibility clinical investigation to assess the safety, tolerability and feasibility of YntraDose™ treatment following percutaneous administration under US/CT guidance.
| Arm | Type | Receives |
|---|---|---|
| YntraDose™ implantation | Experimental | Device: Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreasYntraDose™ is a single use radiotherapy medical device containing Yttrium-90 microspheres administered intratumourally and percutaneously into the pancreas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically proven Pancreatic Adenocarcinoma.
- Stage of disease defined as unresectable Locally Advanced 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Key exclusion criteria (10 listed)
- Evidence of distant metastases based on the restaging process after two months of induction chemotherapy identified using CT/MRI/18 FDG PET assessment.
- Evidence of switch from unresectable status to resectable status of disease after two months of induction chemotherapy.
- More than one primary lesion, if one of the primary lesions is not a good candidate for debulking with YntraDose™, due to clinical reasons and/or decision made by the local MDTB.
- ECOG is higher than 1.
- History of malignancy in the last 3 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreasYntraDose™ is a locoregional therapy device used for percutaneous radio-ablation of solid tumours | Device | YntraDose™ implantation |
Primary outcome
Safety and tolerability assessment
Time frame: From commencement of induction chemotherapy (immediately following screening) to the end of the follow up period at 3 months.
The primary endpoint is safety and tolerability and will be measured by the frequency of treatment-emergent adverse events (TEAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v5.0).
Feasibility of administration of the medical device
Time frame: From implantation of the medical device to the end of the follow up period at 3 months.
To evaluate the feasibility of YntraDose™ percutaneous administration under US/CT guidance for implant in the target tumour lesion, without major clinical complications defined as needing medical intervention to resolve any significant adverse event or medical issue arising from the administration of YntraDose™.
4 secondary outcomes
Patient Quality of Life
Time frame: From enrollment to the end of the follow up period at 3 months.
Pain Assessment
Time frame: Pain assessments will be collected during the 2 pre-implantation screening visits and at 1 week, 1 month, 2 months and 3 months following implantation of the investigational device.
Patient tumour response following treatment with the medical device
Time frame: From baseline assessments to the end of the follow up period at 3 months.
Metabolic tumour response evaluation
Time frame: From baseline to the to the end of the follow up period at 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Yes. A Clinical Investigation Report will be prepared according to ISO 14155:2020 (Annex D) and UNI EN ISO 14155:2025. The report will be a record of the investigation conduct and findings and will be subject to approval by the Investigators who will sign the final report. Patient data will be analyzed collectively in accordance with the investigation Statistical Analysis Plan. Individual patients will not be identified in any report, presentation or publication resulting from the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Locally Advanced, run by BetaGlue Therapeutics SpA at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol Hegarty, PhD (+44 7752 303229, c.hegarty@betaglue.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability assessment (time frame: From commencement of induction chemotherapy (immediately following screening) to the end of the follow up period at 3 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.