Early feasibility study on YntraDose a neoadjuvant radiotherapy device
Research type
Research Study
Full title
Early Feasibility clinical investigation using a novel 90-Yttrium-based internal radiotherapy platform, called YntraDose™ in unresectable Locally Advanced Pancreatic Adenocarcinoma (LA-PDAC) as an addon therapy to first line SoC (chemotherapy)
IRAS ID
360512
Contact name
Paul Ross
Contact email
Sponsor organisation
Betaglue Therapeutics SpA
Clinicaltrials.gov Identifier
Publication of this data is currently deferred.
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
This early feasibility study aim to evaluate the safety, tolerability and feasibility of a new radiotherapy called YntraDose, used alongside standard of care (SoC) chemotherapy, in people with unresectable locally advanced pancreatic ductal adenocarcinoma (LA-PDAC).\nPDAC is one of the major causes of death in the Western world, and it is estimated to become the second leading cause of tumour-related mortality in the next 10 years. Among pancreatic cancers, ductal adenocarcinomas are by far the most common, characterised by a challenging diagnosis due to the lack of initial and pathognomonic clinical signs. Non-metastatic LAPC accounts for a large proportion of all new pancreatic ductal adenocarcinoma diagnoses. LAPC usually includes tumours that are not resectable due to vascular involvement. As of today, treatment is limited, and the prognosis is very unfavourable. Curative-intent surgery remains the gold-standard even if often jeopardized by vascular involvement. \nYntraDose is being tested as a neoadjuvant therapy alongside SoC chemotherapy, with the aim of shrinking the tumour, making it easier to remove surgically or even potentially converting an unresectable tumour into a resectable one. In this study a device called YntraDose will be used to deliver a precise dose of radiation percutaneously and directly into the tumour using a syringe inserted through the skin and guided by ultrasound. This local delivery is intended to limit damage to healthy surrounding tissues. This study represents an early feasibility clinical investigation with a sample size of 10 participants taking part in the UK and two other European countries. All participants will receive standard chemotherapy (either FOLFIRINOX or gemcitabine/nab-paclitaxel). About two months later, if they still meet the inclusion criteria, they will receive the YntraDose implant. Patients will participate in the study for approximately 7 months and will go through: a one month screening period, 2 months of standard chemotherapy, a 2-week reassessment, the implant procedure and a 3-month follow up period.\nThe study is an open label, prospective clinical investigation and all patients will receive the same treatment and undergo the same study procedures including, blood tests, imaging assessments including CT/MRI/ Y90 CT-PET-SPECT/18F-FDG-PET, ECG, health questionnaires, pain assessments and vital signs/physical exams.\n
REC name
London - Stanmore Research Ethics Committee
REC reference
25/LO/0696
Date of REC Opinion
23 Oct 2025
REC opinion
Further Information Favourable Opinion