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

Condition(s) studied

Investigational drug(s) / intervention(s)

Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas: YntraDose™ is a locoregional therapy device used for percutaneous radio-ablation of solid tumours

Study 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

Primary outcome measure(s)

• Safety and tolerability assessment — 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 — 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™.

Trial sites (2)