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

Cancer Clinical Trial

Official title:

Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer: Phase II Study for Pain Palliation and Local Tumor Control

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT01786850
• Other study ID #: Pancreafus-01
• Status: Available
• Phase: N/A
• First received: February 5, 2013
• Last updated: June 17, 2014

Study information

• Verified date: June 2014
• Source: University of Roma La Sapienza
• Contact: alessandro napoli, MD, PhD
• Phone: +390649974540
• Email: alessandro.napoli[@]uniroma1.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Expanded Access

Clinical Trial 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 However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Cancer
• Locally Advanced Pancreatic Cancer
• Non-invasive Treatment
• Pancreas
• Pancreatic Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Italy	Sapienza University of Rome, Policlinico Umberto I Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy,