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

NCT01786850 | Unknown

• 1 other identifier: Pancreafus-01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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 However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is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

Keywords

Locally advanced Pancreatic Cancer; Noninvasive treatment; High Intensity focused ultrasound; Magnetic Resonance

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• contraindication to MR or general anesthesia

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome, Policlinico Umberto I Hospital

Rome, Italy

AVAILABLE

MeSH Terms

Conditions

Neoplasms

Study Officials

• alessandro napoli

  Sapienza University of Rome, Policlinico Umberto I Hospital

  PRINCIPAL INVESTIGATOR

• carlo catalano

  Sapienza University of Rome, Policlinico Umberto I Hospital

  STUDY CHAIR

• michele anzidei

  Sapienza University of Rome, Policlinico Umberto I Hospital

  STUDY DIRECTOR

Central Study Contacts

alessandro napoli, MD, PhD

CONTACT

+390649974540; alessandro.napoli@uniroma1.it

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 8, 2013
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

IT (1)