Using High Intensity Focused Ultrasound to treat unresectable pancreatic tumors
Phase I/II Study Evaluating the Safety and Efficacy of the HIFU Technique in Patients With Unresectable Pancreatic Tumor
This study is testing whether High Intensity Focused Ultrasound can safely treat patients with advanced pancreatic tumors that can't be removed by surgery and who haven't had success with chemotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Leon Berard Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Clermont-Ferrand, Auvergne Rhone-Alpes and 1 other locations) |
| Trial ID | NCT06211933 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of High Intensity Focused Ultrasound (HIFU) for patients with locally advanced and unresectable pancreatic tumors. It consists of a Phase I component that assesses the tolerance of HIFU during surgery, followed by a Phase II component that examines the preliminary effectiveness of this treatment. Patients will be monitored closely throughout the trial, and the study aims to provide a new treatment option for those who have not responded well to chemotherapy. The trial is conducted at multiple centers, focusing on patients who have undergone prior chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed unresectable pancreatic adenocarcinoma that has not progressed after initial chemotherapy.
Not a fit: Patients with pancreatic tumors that are resectable or those who have not undergone prior chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced pancreatic cancer who currently have limited treatment choices.
How similar studies have performed: While HIFU is a relatively new approach, other studies have shown promise in using ultrasound technology for tumor treatment, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clermont-Ferrand, Auvergne Rhone-Alpes and 1 other locations
- CHU Estaing — Clermont-Ferrand, Auvergne Rhone-Alpes, France (Not_yet_recruiting)
- Centre Léon Bérard — Lyon, Rhone-alpes, France (Recruiting)
Study contacts
- Study coordinator: Séverine METZGER
- Email: severine.metzger@lyon.unicancer.fr
- Phone: +33 (0)4 78 78 27 86
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.