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

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ClinicalTrials.gov Identifier: NCT01786850
Expanded Access Status : Available
First Posted : February 8, 2013
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):
Alessandro Napoli, University of Roma La Sapienza

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 However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is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


Condition or disease Intervention/treatment
Pancreas Cancer Locally Advanced Pancreatic Cancer Non-invasive Treatment Procedure: Magnetic Resonance-guided High-intensity Focused Ultrasound (MRgFUS)

Study Design
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Study Type : Expanded Access
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

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • 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.
Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786850


Contacts
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Contact: alessandro napoli, MD, PhD +390649974540 alessandro.napoli@uniroma1.it

Locations
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Italy
Sapienza University of Rome, Policlinico Umberto I Hospital Available
Rome, Italy
Contact: alessandro napoli         
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: alessandro napoli Sapienza University of Rome, Policlinico Umberto I Hospital
Study Chair: carlo catalano Sapienza University of Rome, Policlinico Umberto I Hospital
Study Director: michele anzidei Sapienza University of Rome, Policlinico Umberto I Hospital
More Information
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Responsible Party: Alessandro Napoli, MD, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01786850    
Other Study ID Numbers: Pancreafus-01
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: June 18, 2014
Last Verified: June 2014
Keywords provided by Alessandro Napoli, University of Roma La Sapienza:
Locally advanced Pancreatic Cancer
Noninvasive treatment
High Intensity focused ultrasound
Magnetic Resonance
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases