Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer

NCT ID: NCT01786850

Last Updated: 2014-06-18

Basic Information

• Recruitment Status: AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief Summary

Patients with unresectable pancreatic cancer in most of cases cannot benefit from percutaneous ablation modalities, due to high risk of procedure-related complications. Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a feasible treatment option in these patients. However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still unexplored. The aim of this study is to explore feasibility and clinical performance of MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain palliation and local tumor control.

As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate, non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no cases of pancreatic MRgFUS ablation have been reported.

Conditions

Pancreas; Cancer; Locally Advanced Pancreatic Cancer; Non-invasive Treatment

Interventions

Magnetic Resonance-guided High-intensity Focused Ultrasound (MRgFUS)

High intensity focused ultrasound (HIFU) is a non-invasive ablation technique under ultrasound (US) guidance for the treatment of solid tumors. Differently from other ablations, HIFU induces tissue necrosis through short (10-30s) and relatively low grade (60-80 C°) thermal stimulations. Clinical applications of HIFU include uterine fibroids, prostate, hepatic and breast cancer. Selected patients with pancreatic cancer have been treated with US-guided HIFU for both pain control and tumor debulking. The development of a MR guidance for HIFU (MRgFUS) enabled to perform real-time monitoring and precise control of beam direction, temperature changes and deposited thermal dose beyond the capability of conventional US guidance. This system has been approved for the treatment of uterine fibroids and bone metastases in the United States and European Union. As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate ablation modality for unresectable pancreatic cancer.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• biopsy proven unresectable pancreatic adenocarcinoma;
• unable or not willing to undergo chemo-radiation therapy
• Celiac plexus alcoholization failed to control pain symptoms

Exclusion Criteria

• contraindication to MR or general anesthesia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Napoli

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

alessandro napoli

Role: PRINCIPAL_INVESTIGATOR

Sapienza University of Rome, Policlinico Umberto I Hospital

carlo catalano

Role: STUDY_CHAIR

Sapienza University of Rome, Policlinico Umberto I Hospital

michele anzidei

Role: STUDY_DIRECTOR

Sapienza University of Rome, Policlinico Umberto I Hospital

Locations

Sapienza University of Rome, Policlinico Umberto I Hospital

Rome, , Italy

Site Status: AVAILABLE

Countries

Italy

Central Contacts

alessandro napoli, MD, PhD

Role: CONTACT

alessandro.napoli@uniroma1.it

+390649974540

Facility Contacts

alessandro napoli

Role: primary

Other Identifiers

Pancreafus-01

Identifier Type: -

Identifier Source: org_study_id