NCT07155850 Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 10 participants in total. It began in 2026-02-03 with a primary completion date of 2027-02.

Brief 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. 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.

Eligibility Criteria

Inclusion Criteria (Main): * 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. Exclusion Criteria (Main): * 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). * 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).

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