Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer
Primary Purpose
Pancreas, Cancer, Locally Advanced Pancreatic Cancer
Status
Available
Phase
Locations
Italy
Study Type
Expanded Access
Intervention
Magnetic Resonance-guided High-intensity Focused Ultrasound (MRgFUS)
Sponsored by
About this trial
This is an expanded access trial for Pancreas focused on measuring Locally advanced Pancreatic Cancer, Noninvasive treatment, High Intensity focused ultrasound, Magnetic Resonance
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
Sites / Locations
- Sapienza University of Rome, Policlinico Umberto I Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01786850
First Posted
February 5, 2013
Last Updated
June 17, 2014
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01786850
Brief Title
Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer
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
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
5. Study Description
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 However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas, Cancer, Locally Advanced Pancreatic Cancer, Non-invasive Treatment
Keywords
Locally advanced Pancreatic Cancer, Noninvasive treatment, High Intensity focused ultrasound, Magnetic Resonance
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance-guided High-intensity Focused Ultrasound (MRgFUS)
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
alessandro napoli, MD, PhD
Phone
+390649974540
Email
alessandro.napoli@uniroma1.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alessandro napoli
Organizational Affiliation
Sapienza University of Rome, Policlinico Umberto I Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
carlo catalano
Organizational Affiliation
Sapienza University of Rome, Policlinico Umberto I Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
michele anzidei
Organizational Affiliation
Sapienza University of Rome, Policlinico Umberto I Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sapienza University of Rome, Policlinico Umberto I Hospital
City
Rome
Country
Italy
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
alessandro napoli
12. IPD Sharing Statement
Learn more about this trial
Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer
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