Status:
ACTIVE_NOT_RECRUITING
Evaluation of the High Intensity Focused Ultrasound (HIFU) Technique for Patients With Unresectable Pancreatic Tumor Treatment (PULS)
Lead Sponsor:
Centre Leon Berard
Conditions:
Non-Resectable Pancreas Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase I/II, multicenter trial for patients with locally advanced and unresectable pancreatic tumours : * A Phase I evaluating the tolerance of intraoperative High Intensity Focused Ultrasou...
Detailed Description
The PULS study is designed for patients with a locally advanced tumour of the pancreas (known as pancreatic adenocarcinoma) that has previously been treated with several cycles of chemotherapy and can...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06211933
Start Date
June 25 2024
End Date
February 1 2030
Last Update
January 8 2026
Active Locations (2)
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1
CHU Estaing
Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63003
2
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France, 69008