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3 Tesla Magnetic Resonance Guided High Intensity Focused Ultrasound in the Treatment of Pain From Bone Metastases of Solid Tumors

NCT02718404 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-06-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve 3 Tesla MR-HIFU device for treating painful bone metastases.

Conditions

Interventions

PROCEDURE

MR-HIFU Treatment

The Philips MR-HIFU Sonalleve System integrates a high intensity phased array focused ultrasound transducer with a 3 Tesla Magnetic Resonance (MR) imaging system and electromechanical transducer positioning system to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively. At HIFU day (day 0) before treatment patient will be performed a bone lesion MRI and a functional brain MRI.

DRUG

MR contrast media and medications

During the treatment procedure, an intravenous catheter will deliver MR contrast media and medications (such as sedation and analgesics if required) within the MR room.

PROCEDURE

MR images

Following the MR-HIFU procedure, a set of MR images of the target region will be acquired with the use of a MR contrast agent, together with a functional brain MRI.

Sponsors & Collaborators

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Toni Ibrahim, MD · IRST IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-14
Primary Completion
2018-07-04
Completion
2018-08-27

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02718404 on ClinicalTrials.gov