Transcatheter Endovascular Light-activated Ablation (ELA) to Downstage Locally Advanced Pancreatic Cancer – An IDEAL stage IIa Safety study. VasoBLATE
Clearing tumors from blood vessels, so surgeons can operate and patients may live longer
Background
Circa 30-40% of pancreatic cancers can involve intrapancreatic large blood vessels early, making complete tumor resection technically challenging or impossible. A treatment that clears vessels from encasing tumors is needed so more patients can undergo curative surgery. We hypothesize that effective ablation of perivascular tumors is possible through Endovascular Light-activated Ablation (ELA).
Start-up company Vascular Oncology Biotechnologies B.V. completed a dose-escalating proof-of-concept study in a preclinical model, confirming substantial perivascular necrosis can be generated in the pancreas following a dose response, while the vessel wall remained substantially intact 2-7 days after treatment, in a dose independent fashion. Based on these encouraging results we are now initiating a clinical study within the AmsterdamUMC, RadboudUMC and UMC Groningen, as the next logical step.
Objective
Evaluate the safety and feasibility of Endovascular Light-activated Ablation in patients with pancreatic cancer using an endovascular near-infrared laser irradiation.
Design
A near-infrared irradiation system will be developed and interfaced with novel endovascular EPA balloon catheters, including IMDD documentation for METC approval. Treatment planning software will be developed and integrated into a software package ready for use in the clinical study. 12 patients scheduled for distal pancreatectomy with resection of the splenic vessels will be enrolled. Four cohorts will be treated with perivascular EPA utilizing two increasing dose levels and two delivery approaches (i.e. endo-venous and endo-arterial), followed by the scheduled distal pancreatectomy within 3-7 days. Primary endpoint will be safety as measured by complication rate, feasibility of resection post-ELA and histopathological assessment of vessel wall integrity. Lastly the biological effects of endovascular ELA are investigated, focusing on vascular wall damage and immune response.
Andere projecten
In elk PPS-project werken kennisinstellingen, bedrijven en zorgpartijen samen aan een concrete gezondheidsvraag. Bekijk het volledige projectoverzicht.
Bekijk de programma’s
Binnen onze programma’s werken bedrijven, kennisinstellingen en regionale partners samen aan innovaties die bijdragen aan betere gezondheid en zorg.
Bekijk de partnerschappen
Strategische publiek-private partnerschappen (PPP's) zijn meerjarige samenwerkingen tussen bedrijven, kennisinstellingen en andere partijen.
Hoe kunnen we je helpen?
Heb je een vraag of wil je meer weten over Health Holland? We brengen je graag in contact met de juiste mensen, kennis en mogelijkheden om gezondheidsinnovatie te versnellen.
We hebben uw bericht ontvangen
We nemen binnen 3 tot 4 werkdagen contact met je op. Is je vraag dringend? Neem dan gerust direct contact met ons op. Hieronder zie je de contactoptie die het beste past bij je onderwerp.
Opnieuw beginnen
Er ging iets mis bij het versturen van het formulier. Probeer het opnieuw.