Non-Resectable Pancreas CarcinomaPhase 1/2PULSNCT06211933
Evaluation of the High Intensity Focused Ultrasound (HIFU) Technique for Patients With Unresectable Pancreatic Tumor Treatment (PULS)
A Phase 1/2 study testing HIFU intervention in people with Non-Resectable Pancreas Carcinoma, run by Centre Leon Berard at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Resectable Pancreas Carcinoma
- What is being tested?
- HIFU intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2024to Feb 2030
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study Evaluating the Safety and Efficacy of the HIFU Technique in Patients With Unresectable Pancreatic Tumor
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.
Read the 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 cannot be removed by surgery.
Pancreatic adenocarcinomas are often diagnosed at an advanced stage and only 15% to 20% of patients are candidates for surgery to remove the tumour. In the remaining cases, around a third of patients have metastatic disease at the time of diagnosis. The remaining third have locally advanced pancreatic cancer. In these cases, chemotherapy with or without radiotherapy is the standard treatment. The low proportion of patients who can benefit from surgery and the poor response to chemotherapy make the development of new treatments vital and urgent.
For locally advanced cancers, we want to develop and evaluate a new form of treatment based on a medical device using high intensity focused ultrasound (HIFU), after chemotherapy.
HIFU is a recent technology that uses therapeutic ultrasound. All HIFU procedures currently performed are carried out using an extracorporeal approach.
The aim of this research is therefore to assess the safety and efficacy of HIFU ablation of locally advanced pancreatic tumours.
This trial is a two stages (phase I and II) open label non comparative study. The first step of this study is to evaluate the safety of the HIFU intervention on 3 to 6 patients included. Patients will be included one by one, with a safety committee after each intervention. The total number of patients included in phase I will depend on the complications rate : If no serious complications are observed among the first 3 patients treated, the phase II study can begin. If a serious complication is observed, 3 additional patients will be included in phase I. The transition to phase II will be effective if a maximum of 1 complication out of the 6 patients included is observed. In the other cases, if at least 2 serious complications are observed for 3 to 6 patients included, the study will be definitively stopped.
The second step of this study is to evaluate the efficacy of the HIFU intervention on 26 patients including the patients of phase I.
Each patient will be follow for two years after the HIFU intervention. Un update of vital status will be made annually until the last patient's last visit.
Sample size was thus evaluated by analogy with an A'Hern's. If at least 14 successes are observed among 26 patients, HIFU treatment will be considered of interest.
- Conditions
- Non-Resectable Pancreas Carcinoma
- Being tested
- HIFU intervention
- Keywords
- Oncology, Phase I, Phase II, Phase I/II, HIFU, High Intensity Focalised Ultrasounds, Efficacy, Safety, Medical Device
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU interventionProcedure or surgery
HIFU intervention on non resectable pancreatic lesions at day 0 for each patient included
| Study group | Role | What they receive |
|---|---|---|
| HIFU intervention | Experimental | HIFU intervention Receives: Procedure: HIFU intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance profile of HIFU intervention
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
Measured: Up to 30 days after HIFU intervention
Survival rate at 12 months after HIFU intervention
The efficacy of treatment will be assessed by the proportion of patients alive 12 months after HIFU treatment
Measured: Up to 12 months after HIFU intervention
Secondary outcomes (14)
Tumor ablation rate by HIFU
The tumor ablation rate by HIFU is defined by the volume of the area destroyed by HIFU compared to the volume of the pancreatic cancer on the imaging
Measured: Up to 28 days after inclusion
Intra-operative and post-operative complications linked to the HIFU intervention
The Intra-operative and post-operative complications linked to the HIFU intervention will be evaluated by the number of patients with at least one complication according to Clavien Dindo classification appeared during HIFU intervention and until 3 months after HIFU intervention
Measured: Up to 3 months after HIFU intervention
Feasibility of HIFU intervention
The feasibility of HIFU intervention will be evaluated by the rate of patients who were able to benefit from HIFU intervention. The reasons for non-completion will be described.
Measured: Up to 28 days after inclusion
Progression-Free Survival (PFS)
The Progression-Free Survival (PFS) will be defined as the time from the date of HIFU intervention to the date of first documented disease progression or the date of death due to any cause or until the date of the last update for patients without progression
Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first or until the date of the last update for patients without progression, assessed up to 60 months after inclusion
Local Progression-Free Survival (local PFS)
The local Progression-Free Survival (local PFS) will be defined as the time from the date of HIFU intervention to the date of first local progression
Measured: From date of inclusion to the date of first disease progression or death or last update, assessed up to 60 months
Overall Survival (OS)
The Overall Survival (OS) will be defined as the time from date of HIFU intervention to the date of death, from any cause. Patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
Measured: From date of inclusion to the date of death or date of last update, assessed up to 60 months
Length of hospitalization
The length of hospitalization will be calculated by number of days from the date of the HIFU intervention until the date of discharge from hospitalization
Measured: From date of HIFU intervention to the date of discharge from hospitalization, assessed up to 3 months
Rehospitalization rate during the first 30 days after HIFU intervention.
The rehospitalization rate during the first 30 days after HIFU intervention will be calculated by the number of patients rehospitalized during the first 30 days after HIFU intervention compared to the total number of patients who received HIFU intervention
Measured: From the date of HIFU intervention to 30 days after HIFU intervention
Rate of secondary resectability
The secondary resectability will be calculated by the number of patients eligible for curative pancreatic resection following HIFU intervention compared to the total number of patients who received HIFU intervention
Measured: From date of HIFU intervention to the date of last patient's last visit, assessed up to 60 months
Incidence and severity of adverse events
Descriptive statistics will be used to describe the tolerance profile to HIFU intervention. The incidence and severity of adverse events (AEs), HIFU procedure-related AEs, Serious Adverse Events (SAEs), and deaths will be graded according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) classification.
Measured: From the date of intervention to the date of last patient's last visit, assessed up to 60 months.
Quality of Life (QoL)
The patient's Quality of Life (QoL) will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire C30 file. The questionnaire includes 30 questions whose scores will be calculated at each time point according to the scoring manuals of EORTC. Descriptive statistics will be used to evaluate baseline scores and evolution of scores from inclusion to each time point. The QoL data will also be presented graphically.
Questions 1 to 28 will be evaluated by a score from 1 to 4, 1 being the best outcome and 4 the worse and questions 29 and 30 will be evaluated by a score from 1 to 7, 1 being the worse outcome and 7 being the best.
Measured: From the date of inclusion to 6 months after HIFU intervention
Clinical benefice rate regarding pain
The clinical benefice rate regarding pain will be calculated by the number of patients showing an improvement in pain from inclusion to the end of study, compared to the total number of patients who received HIFU intervention. Pain will be assessed by an analog visual scale (0 to 10 scale, 0 being the best score and 10 the worse).
Measured: From the date of inclusion to the date of last patient's last visit, assessed up to 60 months.
Clinical benefice rate regarding weight
The clinical benefice rate regarding weight will be calculated by the number of patients showing an improvement in weight (in kilograms) from inclusion to the end of study, compared to the total number of patients who received HIFU intervention. A 10% or more increase of weight will be considered as a weight improvement.
Measured: From the date of inclusion to the date of last patient's last visit, assessed up to 60 months.
Clinical benefice rate regarding performance status
The clinical benefice rate regarding performance status will be calculated by the number of patients showing an improvement in performance status from inclusion to the end of study, compared to the total number of patients who received HIFU intervention. Performance status will be assessed by the Eastern Cooperative Group of Oncology (ECOG) score.
Measured: From the date of inclusion to the date of last patient's last visit, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start25 Jun 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2030 (estimated)
Why it stopped: Following a decision by the industrial partner, it was decided to permanently close the study to new participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Resectable Pancreas CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- HIFU intervention at day 0 for each patient included.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211933
- Sponsor's protocol ID
- ET23-247 (PULS)
- Acronym
- PULS
- Status last verified
- Sep 2026
- First submitted
- 20 Dec 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study Evaluating the Safety and Efficacy of the HIFU Technique in Patients With Unresectable Pancreatic Tumor
- ClinicalTrials.gov ID
- NCT06211933
- Acronym / sponsor ID
- PULS / ET23-247 (PULS)
- Conditions
- Non-Resectable Pancreas Carcinoma
- Keywords
- Oncology, Phase I, Phase II, Phase I/II, HIFU, High Intensity Focalised Ultrasounds, Efficacy, Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Following a decision by the industrial partner, it was decided to permanently close the study to new participants.
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 cannot be removed by surgery.
Pancreatic adenocarcinomas are often diagnosed at an advanced stage and only 15% to 20% of patients are candidates for surgery to remove the tumour. In the remaining cases, around a third of patients have metastatic disease at the time of diagnosis. The remaining third have locally advanced pancreatic cancer. In these cases, chemotherapy with or without radiotherapy is the standard treatment. The low proportion of patients who can benefit from surgery and the poor response to chemotherapy make the development of new treatments vital and urgent.
For locally advanced cancers, we want to develop and evaluate a new form of treatment based on a medical device using high intensity focused ultrasound (HIFU), after chemotherapy.
HIFU is a recent technology that uses therapeutic ultrasound. All HIFU procedures currently performed are carried out using an extracorporeal approach.
The aim of this research is therefore to assess the safety and efficacy of HIFU ablation of locally advanced pancreatic tumours.
This trial is a two stages (phase I and II) open label non comparative study. The first step of this study is to evaluate the safety of the HIFU intervention on 3 to 6 patients included. Patients will be included one by one, with a safety committee after each intervention. The total number of patients included in phase I will depend on the complications rate : If no serious complications are observed among the first 3 patients treated, the phase II study can begin. If a serious complication is observed, 3 additional patients will be included in phase I. The transition to phase II will be effective if a maximum of 1 complication out of the 6 patients included is observed. In the other cases, if at least 2 serious complications are observed for 3 to 6 patients included, the study will be definitively stopped.
The second step of this study is to evaluate the efficacy of the HIFU intervention on 26 patients including the patients of phase I.
Each patient will be follow for two years after the HIFU intervention. Un update of vital status will be made annually until the last patient's last visit.
Sample size was thus evaluated by analogy with an A'Hern's. If at least 14 successes are observed among 26 patients, HIFU treatment will be considered of interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- HIFU intervention at day 0 for each patient included.
| Arm | Type | Receives |
|---|---|---|
| HIFU intervention | Experimental | Procedure: HIFU interventionHIFU intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFU interventionHIFU intervention on non resectable pancreatic lesions at day 0 for each patient included | Procedure or surgery | HIFU intervention |
Primary outcome
Tolerance profile of HIFU intervention
Time frame: Up to 30 days after HIFU intervention
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
Survival rate at 12 months after HIFU intervention
Time frame: Up to 12 months after HIFU intervention
The efficacy of treatment will be assessed by the proportion of patients alive 12 months after HIFU treatment
14 secondary outcomes
Tumor ablation rate by HIFU
Time frame: Up to 28 days after inclusion
Intra-operative and post-operative complications linked to the HIFU intervention
Time frame: Up to 3 months after HIFU intervention
Feasibility of HIFU intervention
Time frame: Up to 28 days after inclusion
Progression-Free Survival (PFS)
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first or until the date of the last update for patients without progression, assessed up to 60 months after inclusion
Local Progression-Free Survival (local PFS)
Time frame: From date of inclusion to the date of first disease progression or death or last update, assessed up to 60 months
Overall Survival (OS)
Time frame: From date of inclusion to the date of death or date of last update, assessed up to 60 months
Length of hospitalization
Time frame: From date of HIFU intervention to the date of discharge from hospitalization, assessed up to 3 months
Rehospitalization rate during the first 30 days after HIFU intervention.
Time frame: From the date of HIFU intervention to 30 days after HIFU intervention
Rate of secondary resectability
Time frame: From date of HIFU intervention to the date of last patient's last visit, assessed up to 60 months
Incidence and severity of adverse events
Time frame: From the date of intervention to the date of last patient's last visit, assessed up to 60 months.
Quality of Life (QoL)
Time frame: From the date of inclusion to 6 months after HIFU intervention
Clinical benefice rate regarding pain
Time frame: From the date of inclusion to the date of last patient's last visit, assessed up to 60 months.
Clinical benefice rate regarding weight
Time frame: From the date of inclusion to the date of last patient's last visit, assessed up to 60 months.
Clinical benefice rate regarding performance status
Time frame: From the date of inclusion to the date of last patient's last visit, assessed up to 60 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HIFU intervention in people with Non-Resectable Pancreas Carcinoma, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance profile of HIFU intervention (time frame: Up to 30 days after HIFU intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.