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Sound waves take aim at pancreatic tumors: new trial tests HIFU

NCT ID NCT06211933

Disease control Sponsor: Centre Leon Berard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This trial tests a procedure called High-Intensity Focused Ultrasound (HIFU) for people with pancreatic cancer that cannot be removed by surgery. The study has two parts: first, checking how safe the procedure is, and second, seeing if it helps patients live longer. About 26 participants will receive a single HIFU treatment directly on the tumor during surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-Intensity Focused Ultrasound (HIFU)
What this could lead to
If successful, HIFU could offer a new treatment option for patients with pancreatic tumors that cannot be surgically removed, potentially improving survival.
What could go wrong
This is an early-phase trial with only 26 participants, and the study is currently suspended. The procedure carries risks of serious complications, and it is unclear if it will meaningfully extend life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm neoplasm pancreatic adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-resectable pancreas carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Léon Bérard

    Lyon, Auvergne-Rhône-Alpes, 69008, France

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