Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBetaGlue Therapeutics SpA
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas
DeviceYntraDose™ is a locoregional therapy device used for percutaneous radio-ablation of solid tumours
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: YntraDose™ implantationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability assessment
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).
Time frame
From commencement of induction chemotherapy (immediately following screening) to the end of the follow up period at 3 months.2
Feasibility of administration of the medical device
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™.
Time frame
From implantation of the medical device to the end of the follow up period at 3 months.Secondary outcomes
1
Patient Quality of Life
To evaluate the patient's quality of life using the EORTC QLQPAN26 assessment questionnaire, for people with pancreatic ductal adenocarcinoma (PDAC).
Time frame
From enrollment to the end of the follow up period at 3 months.2
Pain Assessment
Pain will be assessed using a 11-point NPRS (Numerical Pain Rating Scale). collected at screening and during the follow up period.
Time frame
Pain assessments will be collected during the 2 pre-implantation screening visits and at 1 week, 1 month, 2 months and 3 months following implantation of the investigational device.3
Patient tumour response following treatment with the medical device
To evaluate the change in the tumour marker carbohydrate antigen (CA) 19-9 levels comparing baseline levels to the (CA) 19-9 levels at follow up.
Time frame
From baseline assessments to the end of the follow up period at 3 months.4
Metabolic tumour response evaluation
Metabolic tumour response according to \[18F\]2-fluoro-2-deoxy-Dglucose positron emission tomography (18F-FDG-PET) will be measured at baseline and subsequent follow-up time points, for total lesion glycolysis (TLG), standardised uptake values SUVMax and SULMax, target tumour volume change as imaged by CT scans.
Time frame
From baseline to the to the end of the follow up period at 3 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov