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:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT06211933
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years at the day of consenting to the study
* Patient with histologically confirmed locally advanced (unresectable) pancreatic adenocarcinoma according to the National Comprehensive Cancer Network (NCCN) 2020 classification
* Unifocal pancreatic lesion with a maximum diameter of 4 cm
* Non-progressive disease after 4 months of first-line chemotherapy or after 2 months of chemotherapy in case of limiting toxicity contraindicating continuation of chemotherapy;
* Preoperative imaging including CT-scan, MRI of the liver and Positron Emission Computed Tomography scan (PET-CT scan) (except for absolute medical contraindications), within 4 weeks prior to HIFU treatment
* Eastern Cooperative Oncology Group performance status ≤ 2
* Adequate hematologic parameters defined by platelets ≥ 100 Giga/l and hemoglobin ≥ 8 g/dl
* Ability to understand and willingness for follow-up visits
* Patient affiliated to a health insurance scheme (or beneficiary of such a scheme)
* Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment
Exclusion Criteria:
* Local recurrence of previously operated pancreatic cancer
* Metastatic pancreatic carcinoma
* History of major pancreatic resection
* Chemotherapy completed less than 2 weeks ago
* History of radiotherapy to the pancreas
* Pregnant women
* Possibility of R0 resection with venous reconstruction
* Inability to undergo study follow-up for geographical, social or psychological reasons
* Patient requiring tutorship or curatorship or patient deprived of liberty
* Patient under psychiatric care against his wishes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06211933
Study Brief:
Protocol Section:
NCT06211933