SuspendedPhase 1/2

Evaluation of the High Intensity Focused Ultrasound (HIFU) Technique for Patients With Unresectable Pancreatic Tumor Treatment (PULS)

Stopped: Following a decision by the industrial partner, it was decided to permanently close the study to new participants.

France26 participantsStarted 2024-06-25

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tolerance profile of HIFU intervention

Timeframe: Up to 30 days after HIFU intervention

Survival rate at 12 months after HIFU intervention

Timeframe: Up to 12 months after HIFU intervention

Trial details

NCT IDNCT06211933

SponsorCentre Leon Berard

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02

View on ClinicalTrials.gov More Non-Resectable Pancreas Carcinoma trials