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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.

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.

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.

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.

MR-HIFU Treatment

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.

MR contrast media and medications

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.

MR images

Toni Ibrahim, MD

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

This study is a single centre, single arm, non-randomized, non-blinded study. All eligible subjects will receive MR-HIFU therapy, and no blinding is necessary.

All patients will receive one session of MR-HIFU treatment with the Philips Sonalleve MR-HIFU device on the most painful of their bone metastases.

Will be enrolled in the study consecutive patients with painful skeletal metastases from any solid tumours. Patients with all severity grade of pain (mild, moderate and severe pain) will be included in the study.

At HIFU day (day 0) before treatment patient will be performed a bone lesion MRI and a functional brain MRI. The functional brain MRI is not clinical practice: it is not dangerous for the patient, it only involves a longer time of exam for the patient in the MRI site.

A Brief Pain Inventory, a EORTC-quality of life questionnaire-C15-paired-associate learning and information about pain medication recording will be collected always before treatment.

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. The body temperature of the patients will be measured prior to the procedure. In the MR room the patients will lie still on the HIFU patient table inside the MRI magnet. The operator will locate the target tissue and mark the volume to be treated using MRI images. The operator starts the treatment and monitors the progress of the treatment with MR thermal and dose maps according to the Sonalleve Instructions for Use to ensure safety. 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. The functional brain MRI is not clinical practice: it is not dangerous for the patient, it only involves a longer time of exam for the patient under the MRI tunnel. Patients will return for follow-up appointments on Day 14, 30, 60 and 90 for clinical examination. Clinical examination will include inspection and palpation of the treated area and assessment of functionality (e.g. walking pattern or range of movement). The Brief Pain Inventory and the EORTC-quality of life questionnaire will also be administered (to be completed by the patient), and pain medication usage and any possible adverse events will be recorded. Additionally, bone MRI of the treated site and functional brain MRI images will be acquired at 30 and 90 days after treatment.

STATISTICAL CONSIDERATIONS To calculate the sample size the optimal two-stage design developed by Simon is used (Richard Simon, Controlled Clinical Trials 1989). Considering a 2 stage study, with a difference p1-p0=20% between a standard treatment (p0=40%) and the investigated treatment (p1=60%) and setting alfa error probability at 0.10 and beta error probability at 0.10, 28 patients will have to be treated in the 1st stage of the trial. If less or equal than 11 responses are observed among the 28 patients, then the study will be stopped. Otherwise the study will continue to a total of 41 patients will be treated in the second stage. If there are more than 20 responses in 41 patients in the second stage, this treatment could be considered active.

The Intent-to-treat (ITT) population is defined as the population of all enrolled patients. The per-protocol population is considered as all patients in the ITT population except those who prove non to be eligible after enrollment, who withdraw before the MR-HIFU treatment or who commit major protocol violations. The safety population as considered as all patients in the ITT population who underwent to MR-HIFU treatment.

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

3 Tesla Magnetic Resonance Guided High Intensity Focused Ultrasound (MR-HIFU) in the Treatment of Pain From Bone Metastases of Solid Tumors

multidimensional score: the Brief Pain Inventory

calculated as time from MR-HIFU to pain palliation (achievement of CR or PR)

calculated as time from MR-HIFU to pain progression.

calculated as time from pain palliation to pain progression.

As proxy measure of "Ongoing or background pain" will be assumed the "present pain intensity"

measured on the EORTC-QLQ-C15-PAL scale12

reduction of metastatic lesion, number of patients with partial or complete response at 30 and 90 days according to MD Anderson criteria and PERCIST criteria.

Incidence of adverse events

• Incidence of treatment-related adverse events: i. device-related adverse events (resulting from MR-HIFU treatment) ii. study-related adverse events (resulting from protocol-specific procedures)

relation to pain relief and local tumor control at the same timepoints repect to the baseline levels.

involved in oncological pain at rest, and the contrast between the brain regions activated before and after the MR-HIFU procedure, related to perceived pain.

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Infective Agents

Metronidazole

The total validation cohort is composed of axial T2-weighted images of the prostate obtained from 31 prostate MRIs on a 3T unit randomly chosen among the prostate MRIs performed at the Hospices Civils de Lyon in 20162015-2019

The total validation cohort is composed of axial T2-weighted images of the prostate obtained from 31 prostate MRIs on a 1.5T unit randomly chosen among the prostate MRIs performed at the Hospices Civils de Lyon in 20162015-2019

The algorithm is used to perform a multizone segmentation of the prostate including delineation of : the whole prostate contours, the transition zone contours, the anterior fibromuscular stroma.

The contours is independently corrected by 2 radiologists. The corrected contours of the different zones will be stored and for each zone 6 different metrics will be used to evaluate the difference between the initial and corrected contours:

* Mean Mesh Distance: Average Boundary Distance (ABD) for each point of the reference segmentation. The distance to the closest point of the compared segmentation is first computed. Then the average of all these distances is computed and gives the ABD
* General Hausdorff distance (HD)
* 95% percentile (P) of the HD and the 95th (P) of the asymmetric HD distribution
* 95% HD modified (HD95_1): different approach by first computing the 95th (P) of the asymmetric HD then taking the maximum
* Dice coefficient
* Difference in volumes

Comparison of prostate multi-zone segmentation obtained with an automatic deep learning-based algorithm and two expert radiologists

Olivier ROUVIERE, Pr

Because the diagnostic criteria for prostate cancer are different in the peripheral and the transition zone, prostate segmentation is needed for any computer-aided diagnosis system aimed at characterizing prostate lesions on magnetic resonance (MR) images. Manual segmentation is time consuming and may differ between radiologists with different expertise. We developed and trained a convolutional neural network algorithm for segmenting the whole prostate, the transition zone and the anterior fibromuscular stroma on T2-weighted images of 787 MRIs from an existing prospective radiological pathological correlation database containing prostate MRI of patients treated by prostatectomy between 2008 and 2014 (CLARA-P database).

The purpose of this study is to validate this algorithm on an independent cohort of patients.

Deep Learning for Prostate Segmentation

Multi-zone Computer-aided Prostate Segmentation on MR Images Using a Deep Learning-based Approach

The Mean Mesh Distance corresponds to the Average Boundary Distance (ABD) for each point of the reference segmentation. The distance to the closest point of the compared segmentation is first computed. Then the average of all these distances is computed and gives the ABD.

The Mean Mesh Distance between the contours of the whole prostate made by the algorithm and each radiologist will be used as primary outcome measure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
3 Tesla Magnetic Resonance Guided High Intensity Focused Ultrasound in the Treatment of Pain From Bone Metastases of Solid Tumors	NCT02718404	Solid Tumors	MR-HIFU Treatme... MR contrast med... MR images	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Deep Learning for Prostate Segmentation	NCT04191980	Prostate Cancer	Comparison of p...	18 Years -	Hospices Civils de Lyon
Deep Learning for Prostate Segmentation	NCT04191980	Prostate Cancer	Comparison of p...	18 Years -	Hospices Civils de Lyon

Spots Global Cancer Trial Database for mr images

Every month we try and update this database with for mr images cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mr images

Every month we try and update this database with for mr images cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mr images cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.