Skip to content

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

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

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01786850
Enrollment
Unknown
Registered
2013-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2014-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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 However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is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

Interventions

PROCEDUREMagnetic 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.

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

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

Countries

Italy

Contacts

Primary Contactalessandro napoli, MD, PhD
alessandro.napoli@uniroma1.it+390649974540

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026