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

NCT06211933 | Suspended Phase 1 DMC

• 1 other identifier: ET23-247 (PULS)
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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 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

Non-Resectable Pancreas Carcinoma

Keywords

Oncology; Phase I; Phase II; Phase I/II; HIFU; High Intensity Focalised Ultrasounds; Efficacy; Safety; Medical Device

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Up to 12 months after HIFU intervention

Secondary Outcomes (14)

• Tumor ablation rate by HIFU

  Up to 28 days after inclusion

• Intra-operative and post-operative complications linked to the HIFU intervention

  Up to 3 months after HIFU intervention

• Feasibility of HIFU intervention

  Up to 28 days after inclusion

• Progression-Free Survival (PFS)

  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)

  From date of inclusion to the date of first disease progression or death or last update, assessed up to 60 months

Study Arms (1)

HIFU intervention

EXPERIMENTAL

HIFU intervention

Procedure: HIFU intervention

Interventions

HIFU intervention PROCEDURE

HIFU intervention on non resectable pancreatic lesions at day 0 for each patient included

HIFU intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (2)

CHU Estaing

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63003, France

Location

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, 69008, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: HIFU intervention at day 0 for each patient included.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 18, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

FR (2)