Clinical trial · Interventional
Evaluation of the High Intensity Focused Ultrasound (HIFU) Technique for Patients With Unresectable Pancreatic Tumor Treatment (PULS)
Phase I/II Study Evaluating the Safety and Efficacy of the HIFU Technique in Patients With Unresectable Pancreatic Tumor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Why stopped (as posted): Following a decision by the industrial partner, it was decided to permanently close the study to new participants.
Summary
Brief summary (as posted)
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 Ultrasound (HIFU) intervention on the pancreatic lesion. * A non-randomized Phase II evaluating the preliminary efficacy of the HIFU intervention on the pancreatic lesion. Patients included in Phase I will be monitored and included in the Phase II evaluation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Resectable Pancreas Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIFU intervention | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIFU intervention
- description
- HIFU intervention
- interventionNames
- Procedure: HIFU intervention
Primary outcomes (2)
- measure
- Tolerance profile of HIFU intervention
- timeFrame
- Up to 30 days after HIFU intervention
- description
- The tolerance of HIFU intervention will be assessed by the number of patients presenting at least one serious complication during the first 30 days after HIFU intervention. A serious complication corresponds either to any grade 3 or more complication according Clavien-Dindo classification or any vascular complication treated by interventional radiology
- measure
- Survival rate at 12 months after HIFU intervention
- timeFrame
- Up to 12 months after HIFU intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available