Clinical Study

Now recruiting · Pancreatic cancer

The YntraDose® clinical study

An early feasibility study of a novel Yttrium-90 beta-radiation implant, delivered directly into the tumour in unresectable locally advanced pancreatic cancer (LA-PDAC).

Contact a recruitment centre Now recruiting in the UK & Belgium
Y-90 microspheres delivered to the tumour target
The study

What is the YntraDose® clinical study?

This early feasibility study represents the first use of the YntraDose® product in patients with unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC). It evaluates the product's ability to safely deliver radiation directly to the pancreatic tumour and assesses patients' response to treatment. The study is a multicentre, open-label design — meaning all patients receive the same treatment.

Discover the study

A precise, minimally invasive approach

Study treatment

A Y-90 beta-radiation implant

YntraDose® is a novel radiotherapy medical device that delivers highly localised beta radiation directly into tumour tissue, via a percutaneous injection of Yttrium-90 (Y-90) radioactive microspheres.

Primary purpose

Safety & performance

To evaluate the safety, technical performance and procedural experience of this novel beta-radiation implant in patients with pancreatic solid tumours.

Study duration

One administration, close follow-up

About 7 months of active participation, then a 12-month observation phase. Patients receive a single administration of YntraDose®, alongside their scheduled standard chemotherapy.

What participation looks like

The patient journey, step by step

YntraDose® is given once, between chemotherapy cycles. Here is what taking part involves.

  1. 1

    Standard chemotherapy ~2 months

    Patients first receive their standard chemotherapy for about two months.

  2. 2

    Tumour reassessment

    Doctors reassess the tumour and confirm the patient is still eligible for the study.

  3. 3

    YntraDose® procedure 2-night stay

    Given between chemotherapy cycles as a single administration, with a two-night hospital stay so the team can monitor safety before and after treatment.

  4. 4

    Post-procedure monitoring +3 months

    Patients remain in the study for a further three months to monitor safety and observe any early signs of tumour response.

  5. 5

    Follow-up 12 months

    Health is monitored through a review of medical records — no hospital visits unless the doctor feels one is needed.

~7 monthsActive participation phase
9 visitsHospital visits in the active phase
1Single administration of YntraDose®
12 monthsFollow-up via medical records
Who can participate

Eligibility criteria

This study is open to adults who have not received prior radiotherapy for pancreatic cancer and are diagnosed with unresectable LA-PDAC.

  • Adult patient aged 18 years or older
  • Diagnosed with unresectable locally advanced pancreatic ductal adenocarcinoma
  • Target tumour with a minimum diameter of 2.6 cm and a volume of 9 to 34 mL
  • No prior radiotherapy for pancreatic cancer

Full eligibility criteria

The complete list of inclusion and exclusion criteria is published on the public clinical-trials registry.

View on ClinicalTrials.gov

Study identifier NCT07155850

What we are learning

Objectives of the study

The study looks at how safe and tolerable YntraDose® is alongside standard chemotherapy, and how well it can be placed and how patients respond.

Safety & tolerability

How safe and tolerable YntraDose® is when given alongside standard chemotherapy.

Accurate placement

Whether doctors can safely place the treatment into the tumour using a CT-guided needle procedure.

Patient Experience

To understand patients’ quality of life and symptom experience after treatment with YntraDose®.

CA 19-9 monitoring

Changes in CA 19-9 levels over time, to help understand how the body responds to treatment.

Imaging response

Imaging scans taken before and after treatment are compared to evaluate how the tumour responds.

Contact a recruitment centre

Where the study is recruiting

The YntraDose® study is opening across Europe and the UK. Sites go live as each country's regulatory approval is granted.

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