Actively Recruiting
Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC
Led by BetaGlue Therapeutics SpA · Updated on 2026-02-19
10
Participants Needed
2
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed pancreatic adenocarcinoma
- Disease stage defined as unresectable locally advanced pancreatic cancer
- No previous radiotherapy for pancreatic cancer
- Target tumor size at least 2.6 cm in diameter and tumor volume between 9 and 34 ml
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Acceptable blood counts and liver and kidney function suitable for standard chemotherapy
- Life expectancy of at least 6 months at screening
You will not qualify if you...
- Evidence of distant metastases after two months of induction chemotherapy confirmed by imaging
- Change from unresectable to resectable tumor status after two months of induction chemotherapy
- More than one primary lesion if not all are suitable for treatment with YntraDose12
- Eastern Cooperative Oncology Group (ECOG) performance status higher than 1
- History of malignancy within the last 3 years
- Blood clotting disorders increasing bleeding risk during organ puncture
- Active systemic or local infections such as peritonitis or abscess
- Severe organ failure including end-stage liver, kidney, or heart failure
- Heart or other diseases that increase risk from anesthesia
- Acute pancreatitis or worsening of chronic pancreatitis
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Roma, Italy
Actively Recruiting
2
Guy's & St Thomas' and Kings College Hospitals
London, United Kingdom
Actively Recruiting
Research Team
C
Carol Hegarty, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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