Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT07155850
Eligibility Criteria:
Inclusion Criteria (Main):
* 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.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Patient has acceptable hematological parameters including white and red blood counts, liver and renal function that makes them suitable to receive SoC chemotherapy as per local clinical practice.
* Life expectancy of ≥6 months at screening.
Exclusion Criteria (Main):
* 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.
* History of malignancy in the last 3 years.
* Blood clotting disorders (INR \> 1.5, PLT \< 50,000/µl - risk of bleeding during organ puncture).
* Active systemic or local infection (e.g. peritonitis, abscess).
* Severe organ failure (e.g. end-stage liver, kidney, heart failure).
* Cardiological and other diseases that threaten the use of anesthesia.
* Pancreatitis (acute or exacerbation of chronic inflammation).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07155850
Study Brief:
Protocol Section:
NCT07155850