Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Pain

Neoplastic Processes

All patients undergoing thermal ablation and cementoplasty procedure for one or more painful bone lesion

Percutaneous thermal ablation with subsequent cementoplasty in a single procedure

Ablation and Cementoplasty

Jason K Wong

Stefan Przybojewski

Stefan Przybojewski, MD

The aim of this research study is to assess the effectiveness of combined ablation and cementoplasty in the treatment of spinal, pelvic, and extraspinal lesions causing pain resistant to conventional treatment at our centre. In particular, the investigator seek to verify the safety and efficacy for multiple primary tumor types and benign lesions as well as encompass multiple measurements of outcome, including visual analog scale (VAS) for pain, opioid and analgesic use, and overall performance scales, combined with cross-sectional imaging follow-up to assess tumor burden, to ascertain a comprehensive Canadian single-centre experience that has been lacking in previous studies.

Research Question \& Objectives

1. To conduct a prospective, single-centre study of combined ablation and cementoplasty treatment for painful spinal and extraspinal osseous lesions.
2. Report the technical outcome and safety of percutaneous ablation prior to image-guided cementoplasty in a single treatment session.
3. Review the effectiveness and durability of pain control, local tumor control, and the impact on QoL using ablation and cementoplasty in treating spinal/extraspinal osseous tumors.
4. Assess the feasibility and efficacy of ablation and cementoplasty treatment for different primary tumor types and benign lesions.

Research Design

The investigators will conduct a single-centre, single-arm, cohort analysis of all patients who undergo cementoplasty for osseous disease in the department of interventional radiology over a two-year period. This will be a prospective paired comparison study with patients serving as their own controls. Technical success and procedural complications will be monitored and recorded for all patients. All patients will be followed until death or 3 months post-procedure.

The investigators aim to enroll a minimum of 40 patients referred for symptomatic osseous lesions. Bipolar radiofrequency ablation (Osteocool RFA system, Medtronic) or cryoablation (Visual Ice Cryoablation, Boston Scientific) will be performed under CT, ultrasound, or fluoroscopic guidance at the discretion of the treating radiologist, and immediately followed by cement injection. Radiological outcomes, including local tumor control and disease progression, will be assessed by CT imaging immediately post-procedure as well as 3-month follow-up. Clinical outcomes will be evaluated by VAS, analgesic use, and QoL assessment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) prior to procedure and immediately post-procedure, as well at 1-week, 1-month, and 3-month intervals post-procedure.

Single-arm prospective study of pain and quality of life before and after ablation/cementoplasty procedure

Ablation and Cementoplasty for Painful Bone Lesions

Percutaneous Ablation and Cementoplasty for Painful Bone Lesions: A Canadian Single-Centre Experience

Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The QLQ-C30 is composed of 3 multi-item scales including a functional scale, a global health status/quality of life scale, and a symptom scale. Each scale ranges in score from 0-100 with a higher scale score representing a high/healthy level of functioning, quality of life, and symptomatology/problems, respectively.

Tumor burden as assessed by CT scan following procedure as compared to pre-procedure scan

University of Calgary

Interventional Radiologist; Clinical Associate Professor, University of Calgary

Musculoskeletal Diseases

Blood and Lymph Conditions

Behaviors and Mental Disorders

Rare Diseases

Osteosarcoma

Bone Neoplasms

Neoplasms, Second Primary

Bone Marrow Diseases

Bone Diseases

Hematologic Diseases

Quality of Life

Analgesics

All Drugs and Chemicals

Combination of focused ultrasound and external beam radiotherapy

Following standard EBRT (single or multiple fraction), patients will receive one MR-HIFU treatment with the Profound Sonalleve MR-HIFU device on the most painful of their bone metastases. This treatment will take place in a short time frame of 3 hours to maximum 4 days. Patients will be followed up until 4 weeks after treatment. During follow-up they will be phoned around day 3, 7, 14, 21 and 28 to retrieve pain scores, pain medication and (serious) adverse events. At day 3 the patient's experience with the combined treatment will also be inquired.

combined radiotherapy and MR-HIFU

Helena M Verkooijen, MD, PhD

The PRE-FURTHER study aims to evaluate the feasibility of the combined treatment with radiotherapy and focussed ultrasound for pain palliation in patients with painful bone metastases, and to optimize the combined treatment logistics. Six to ten patients will be included according to in- and exclusion criteria.

Rationale: Metastatic bone pain strongly interferes with quality of life and daily functioning of patients with advanced cancer. Pain palliation may be improved by including magnetic resonance image guided high intensity focused ultrasound (MR-HIFU) in addition to External Beam Radiotherapy (EBRT). For this purpose, feasibility and optimal logistics of the combined treatment need to be evaluated.

Objective: The PRE-FURTHER project aims to evaluate the feasibility of the combined EBRT and MR-HIFU treatment for relief of metastatic bone pain, and to optimize the combined treatment logistics.

Study design: The PRE-FURTHER study is a prospective case series, stage I and IIA study according to the Innovation, Development, Evaluation, Assessment and Long term evaluation (IDEAL) recommendations. 6-10 patients will receive MR-HIFU treatment following standard EBRT.

Endpoints: The main outcome of this study is the feasibility of the procedure, in terms of planability as well as patient-tolerability of the combined treatment within a short time frame (3 hours - 4 days interval). In addition, pain relief and safety of the combined procedure will be monitored.

Prospective case series (n = 6 - 10), stage I and IIA study according to the Innovation, Development, Evaluation, Assessment and Long term evaluation (IDEAL) recommendations. The study will be performed in male and female adult (≥ 18 years) cancer patients capable of giving informed consent and referred for EBRT of painful bone metastases (Numerical Rating Scale (NRS) ≥ 4).

Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis

Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis - the PRE-FURTHER Study -

The main outcome of this study is the feasibility of the combined procedure in terms of patient tolerance and hospital logistics. Patient tolerance will be assessed using a Patient Reported Experience Measure questionnaire.

The main outcome of this study is the feasibility of the combined procedure in terms of patient tolerance and hospital logistics. Hospital logistics will be assessed by analysing comments of the treating physicians and research staff on the problems that occurred during treatment planning, and whether extra hospital visits that were needed.

Patient reported pain scores will be based on a Numeric Rating Scale (from 0 to 10 with 0 being no pain and 10 being the worst pain imaginable) from the Brief Pain Inventory (BPI) questionnaire \[Cleeland 1994\].

Toxicity/safety of the combined treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Isala

UMC Utrecht

Principal Investigator

Infections

Communicable Diseases

8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system

8 Patients with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022

The study is based on a comparison of the number of CT scans required for needle placement in bone biopsies (trunk area) performed with augmented reality navigation system (endosight) and without.

The goal of this clinical study is to evaluate the duration of the procedure, the precision (distance between the needle tip and the centre of the target), and the safety of endosight system in the guidance for bone biopsies.

In this study results obtained in the prospective group will be compared with those obtained in the retrospective group.

Total N° of patients: 16

PROSPECTIVE GROUP (treated WITH the guidance of endosight):

N° of patients: 8

RETROSPECTIVE GROUP (treated WITHOUT the guidance of endosight):

N° of patients: 8

Main objective of the study:

Reduction of execution times by at least 10 minutes; Reduction of the number of CT scans by at least 2 scans.

N°of hospitals involved: 2.

Duration: maximum 6 months from the date of the first enrollment.

No follow-up is expected.

The study is designed to compare a prospective arm composed of 8 patients who were prescribed a CT-Guided bone biopsy (with the aid of endosight navigation system) with a retrospective arm with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022 (without endosight navigation system)

all sensitive data regarding enrolled patients will be transmitted to the Outcomes Assessor anonymously (code assigned to the patient)

Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy

Assessment of Operative Time, Precision, and Safety of an Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy

Change in the total duration of the procedure (calculated from the time of local anesthesia injection to the time of bone sample collection)

Change in overall number of CT scans performed during the procedure (calculated as the total number of CT scans required to reach the target; from the 1° CT-scan (local anesthesia) to the last CT-scan (sample collection from the bone)

Distance between the tip of the needle and the center of the target (from 0mm to 10mm)

Change in the total radiant dose received by the patient (calculated by summing the radiation emitted for each CT-Scan performed from the anesthesia-point to the collection-point)

satisfaction level of the operator (from 0 to 5 - 1: poor satisfaction, 5: high satisfaction)

Total number of major+minor side effects, reported during the procedure

R.A.W. - S.R.L.

Central Nervous System Depressants

Anesthetics

* Pre-treatment imaging
* Pre-treatment questionnaires and laboratory blood samples
* Intervention (Thermal ablation of bone metastasis with MR-HIFU device Philips Sonalleve coupled with Philips Ingenia 3.0T)
* Follow-up (imaging, questionnaires, laboratory)
* Follow-up pain medication usage

* Pre-treatment imaging
* Pre-treatment questionnaires and laboratory blood samples
* Intervention (Varian Truebeam Radiotherapy System)
* Follow-up (imaging, questionnaires, laboratory)
* Follow-up pain medication usage

Procedure is performed under proper analgesia (general or local anesthesia). The intervention can be performed in areas accessible with ultrasound with no critical structures (nerves, vasculature, bowels) in proximity. Limbs and pelvis are most usually accepted locations.

Patient is adjusted on top of the HIFU-transducer connected to MRI. First a MR-scan is performed and the treatment procedure is planned on consol. Then under MRI-guidance a point by point ablation of the target tumor is performed. During the treatment a real-time thermometry is obtained in order to avoid unwanted heating of related structures and to observe sufficient effect on treatment zone. After treatment MR-scan with gadolinium is performed to evaluate the size of ablated area.

Thermal ablation of bone metastasis with MR-HIFU device Philips Sonalleve coupled with Philips Ingenia 3.0T

Conventional radiotherapy focused on bone tumor. Pretreatment planning images acquired with computer tomography

Varian Truebeam Radiotherapy System

Roberto T Blanco Sequeiros, Dosent, MD

Heikki E Pärssinen, MD, PhD Student

Gaber Komar, PhD, MD

Mira Huhtala, MD, PhD student

Heikki Minn, Professor, MD

Teija O Sainio, MSc, PhD Student

Bone metastasis give rise to major complications that lead to significant morbidity and impairment of life quality. The most common primary for bone metastasis is prostate, lung and breast carcinoma. These three have the highest cancer incidence in the USA with up to 85% prevalence of bone metastases at the time of death. Pain from these osseous lesions can be related to mechanical or chemical factors. Pressure effects on the periosteum or adjacent neural structures can cause local or radiating pain. Hemorrhage from local bone osteolysis by osteoclastic activity causes a local release of bradykinin, prostaglandins, histamine and substance P that can irritate the endosteal nerves as well as local nerves.

The life expectancy of patients with osseous metastatic disease is variable but can be substantially longer for patients with multiple myeloma, breast or prostate cancer. Therefore, finding an effective local therapy that can improve patient quality of life and can be done at a single outpatient sitting would be beneficial.

The current and emerging treatments for osseous metastases may be considered in several categories: radiotherapy, systemic chemotherapy (cytotoxic, hormonal and radionuclides), surgical stabilization and percutaneous tumor ablation. These treatments may be applied in isolation but also frequently in combination.

MRI Guided High Intensity Focused Ultrasound (HIFU) is a completely non-invasive technology for thermal ablation. HIFU is capable of concentrating ultrasonic pressure waves to a specified region without any physical penetration of the body. The converging ultrasonic pressure wave is converted to thermal energy at the specific depth, resulting in local heating at the focus. Temperature elevation is proportional to the proton resonance frequency shift, therefore MR imaging provides accurate technique for target definition and energy deposition control. MRI guided Focused Ultrasound therapy is being performed in treatment of uterine leiomyomas (fibroids). Recently the method has gained both AMAR authorization and FDA approval, and CE approval for that indication.

Clinical trials of HIFU in bone metastases have indicated that the method is safe and gives an effective reduction of patient pain. The short- and long-term effects on tumor volume and morphology do not seem to have been evaluated thus far.

The primary objective of this trial is to evaluate effectiveness of MRI guided HIFU in the treatment of metastatic bone tumors

Clinical Background

Bone metastasis give rise to major complications that lead to significant morbidity and impairment of life quality. The most common primary for bone metastasis is prostate, lung and breast carcinoma. These three have the highest cancer incidence in the USA with up to 85% prevalence of bone metastases at the time of death. Pain from these osseous lesions can be related to mechanical or chemical factors. Pressure effects on the periosteum or adjacent neural structures can cause local or radiating pain. Hemorrhage from local bone osteolysis by osteoclastic activity causes a local release of bradykinin, prostaglandins, histamine and substance P that can irritate the endosteal nerves as well as local nerves.

The life expectancy of patients with osseous metastatic disease is variable but can be substantially longer for patients with multiple myeloma, breast or prostate cancer. Therefore, finding an effective local therapy that can improve patient quality of life and can be done at a single outpatient sitting would be beneficial.

Current Treatment of Bone Metastases

The current and emerging treatments for osseous metastases may be considered in several categories: radiotherapy, systemic chemotherapy (cytotoxic, hormonal and radionuclides), surgical stabilization and percutaneous tumor ablation. These treatments may be applied in isolation but also frequently in combination.

External beam radiation therapy (EBRT) is one of the main treatments for osseous metastases. Radiation therapy creates its effect by destroying of the local tumor and inflammatory cells that are responsible for causing pain. Although the effect of radiotherapy to palliate pain and to control osseous metastatic disease is well established., there is significant relapse rate within patients who survived at least 12 weeks. Also the pain relief is often suboptimal leading to supplemental and persisting medication. Thus, the "net pain relief" less than the goal of pain relief for the total duration of life after treatment. Also, there is a limit on how much radiation can be given, this constitutes a problem in clinical oncology care.

Chemotherapy has a variable effect on bone metastases related to a number of neoplasm, drug and patient related factors. Newer systemic treatments with radionuclides and bisphosphanates have shown some success. More recently, the development of recombinant osteoprotegerin and an anti-parathyroid hormone-related protein monoclonal antibody represent promising new options for the treatment of patients with bone metastases. However, there are numbers of important factors to consider such as potential side effects of treatment and unanswered questions regarding the optimal use of systemic agents: when should treatment begin, how long must treatment be continued, and what are the optimal dose and schedule to achieve clinically meaningful anti-tumor effects?

Surgical therapy is essential in certain instances where mechanical strengthening is necessary such as an impending or occurred pathological fracture but it has little role in palliative therapy due to invasiveness and potential complications associated. Therefore, a more effective modality of local treatment for bone metastases could substantially improve quality of life.

More recently, percutaneous procedures for local tumor ablation such as radiofrequency ablation and cryotherapy have shown promise in the treatment of metastatic bone lesions.

MRI Guided High Intensity Focused Ultrasound (HIFU) is a completely non-invasive technology for thermal ablation. HIFU is capable of concentrating ultrasonic pressure waves to a specified region without any physical penetration of the body. The converging ultrasonic pressure wave is converted to thermal energy at the specific depth, resulting in local heating at the focus. Temperature elevation is proportional to the proton resonance frequency shift, therefore MR imaging provides accurate technique for target definition and energy deposition control. MRI guided Focused Ultrasound therapy is being performed in treatment of uterine leiomyomas (fibroids). Recently the method has gained both AMAR authorization and FDA approval, and CE approval for that indication.

Technical background: MR-guided intervention

Since the first report of MR-guided biopsy in 1986 there has been an increasing interest in MR-guided interventions. Technical barriers, such as the inaccessibility to the patient during imaging and the lack of MR-compatible instruments (needles, scissors, etc.) have largely been solved. Today the majority of MR-guided interventions are made in conventional closed-bore scanners alongside diagnostic imaging. Also, MRI guidance is a cost effective approach to perform these minimally invasive procedures and can in many cases replace the more invasive and in-patient based procedures.

New Possibilities: integration of MR imaging with therapy Until recently, control of destructive energy deposition has been an unresolved problem in tumor treatment. One of the greatest potentials of MRI is in monitoring the delivery of various destructive energies. Thermal monitoring is a particularly important application of interventional MRI. Thermal ablation techniques require not only good localization and targeting but also quantitative spatiotemporal control of energy deposition, which in turn requires monitoring of the thermal changes and the resulting tissue alterations.

Hyperthermia is based on slight temperature elevation (about 41° C), which requires relatively long homogenous thermal treatment of solid tumors. The main assumption of hyperthermia is that malignant cells have a higher sensitivity to thermal damage than normal ones. The temperature sensitivity of various MRI parameters (T1, diffusion, and chemical shift) can be exploited for detecting temperature changes within the critical temperature range. Compared with hyperthermia, thermal surgery uses temperatures above 55-60° C, but for a short period only.

Above 55-60 °C, proteins are denatured, and the resulting thermal coagulation causes irreversible tissue damage. Appropriate MRI sequences can demonstrate the normal margins surrounding thermal lesions, where the temperature elevation is still too low to cause cell necrosis, and, most importantly, can differentiate tissue phase transitions.

Since MRI enables monitoring, new possibilities have emerged for interstitial laser therapy, cryo- or RF-ablation and high-intensity focused ultra¬sound treatment of different tumors.

High-Intensity Focused Ultrasound (HIFU) The ability of the ultrasound imaging modality for guidance of minimally invasive procedures has been shown in various disorders but moreover, it has a significant potential to produce coagulation necrosis in exposed tissue by high-power focused sonication. By focusing high-power ultrasound beams at a distance from the source, total necrosis of tissues lying within the focal volume can be achieved without damage to the structures elsewhere in the path of the beam.

Since diagnostic ultrasound images are not sensitive enough to guide focused ultrasound thermal therapy, MRI has been used to guide this intervention. MRI thermometry based on temperature-dependent proton resonance frequency has been shown to accurately reflect thermal changes in tissue. Currently, two types of HIFU-methods are clinically used: point-by-point ablation and volumetric ablation, the latter considered more energy-efficient.

Clinical trials of HIFU in bone metastases have indicated that the method is safe and gives an effective reduction of patient pain. The short- and long-term effects on tumor volume and morphology do not seem to have been evaluated thus far.

Objectives of the study

MRI guided HIFU has been utilized to effect in treating metastatic and bening bone tumors. However detailed information upon treatment effect to pain, to the tumor volume and to the systemic immunological processes are lacking, and there are no prospective studies upon these issues. Furthermore, there is no randomized study comparing HIFU therapy to radiation therapy. There is no data upon HIFU therapy planning utilizing therapy planning software.

The primary objective of this trial is to evaluate effectiveness of MRI guided HIFU in the treatment of metastatic bone tumors:

* Safety: To further evaluate incidence and severity of adverse events associated with MRI-HIFU therapy using novel cooled technique.
* Effectiveness: To determine the effect of MRI-HIFU treatments of metastatic bone tumors. Efficacy will be determined by the level of pain relief (as measured by the Visual Analog Scale; VAS), decrease in analgesics/opiate and improved quality of life (as measured by SF36 questionnaire, in Finnish) from baseline up to 24-Weeks post HIFU treatment.

This study is designed as a prospective, two arm, nonrandomized study (Where one arm will consist of HIFU group and the other from RT group). Later on a wider randomized two arm study comparing outcomes between HIFU and RT could be executed. Furthermore, this study follows the "International Bone Metastases Consensus Working Party" on endpoint measurement for future clinical trials that was established in 2012 in conjunction with the American Society for Therapeutic Radiology and Oncology (ASTRO), the European Society for Therapeutic Radiology and Oncology (ESTRO), and the Canadian Association of Radiation Oncology (CARO)( Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1730-7. doi: 10.1016/j.ijrobp.2011.02.008. Epub 2011 Apr 12.)

Specific Objectives:

1. Pain relief. The change in the patient pain relief will be assessed with the Visual Analog Scale (VAS), whereas the treated patient quality of life will be assessed the quality of life questionnaire. These assessments will be performed at baseline, on treatment day, and at each follow up time point.
2. Additional data regarding dosage and frequency of analgesic consumption for the management of the metastatic bone tumor induced pain will also be collected.
3. Effect on systemic immunological processes, such as tumor markers and cytokines will be monitored via repeated blood samples.
4. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study. This study will be performed on either the 1.5T or 3T MR scanners.
5. Temporal effect of HIFU to tissue as observed with longitudinal imaging.

The ultimate goal of this project is to establish a multidisciplinary mini-invasive environment using a 3 T MR imager with integrated high-intensity focused ultrasound.

Eventually, during the years to come, the goal is to develop and clinically validate the MR-guided HIFU-interventions and place the potential treatment option in a clinical perspective, i.e. with regard to cost, morbidity rate and outcome in following disorders

* metastatic bone disease
* cortical and intra-articular osteoid osteomas
* solitary aggressive (giant cell tumor) or malignant (plasmacytoma) lesions

Patient selection and pre -and postoperative imaging In this first phase, we include patients with intractable pain despite proper analgesics and radiotherapy treatment. These patients should not have more than three bone metastasis planned for treatment, and the source of pain should unambiguously localize to the metastasis that is considered to be sonicated. As this is a preliminary study, the anatomic location should be relatively easily accessible, i.e. the metastases should be located in the pelvic region, shoulders or in the extremities. Exclusion criteria include disease diffusely spread to bones, and the source of pain is not localized to the metastasis. Also, close proximity of a major nerve or artery is considered exclusion criteria. Other contraindications include ASA-class greater than II, when anesthesia during the procedure is required, allergy to MRI contrast medium or anesthetic agents.

MRI unit, HIFU-system and sonication. As a novel image guided therapy platform for a 3-T scanner (Ingenia, Philips Healthcare, Best, The Netherlands) we will utilize completely non-invasive MRI guided High Intensity Focused Ultrasound platform (Sonalleve, Philips Healthcare, Vantaa, Finland) to perform and study the treatment. The high intensity focused ultrasound (HIFU) tabletop harbors a 256- element phased array HIFU transducer (focal length of 140 mm, operating at 1.2 MHz). The system has different ellipsoidal treatment volumes with cross-sectional diameter from 2 to 12 mm.

The patient preparation includes preferably concise sedation e.g. with phentanyl and midazolam. However, the optimal pain relief is always individual, and is based on mutual agreement by the patient and the anesthesiologist specialized in pain relief.

After pre-sonication MR imaging, the targeted volume is defined by the radiologist, and the thermal effect is assessed by the vendor provided pulse-sequences (fast-field echo with echo planar imaging) that enable the proton resonance frequency shift (PRFS) MR thermometry method. The temperature should reach more than 55 degrees for each volume in order to achieve thermal coagulation that causes irreversible tissue damage.

Current status of the work The magnet and sonication instrumentation has been installed in early 2016, and currently the MRI is used for clinical examinations and for HIFU therapy of uterine myomas (fibroids).

Clinical significance MRI guided high-intensity focused ultrasound has the potential to become a cost-saving clinical application of MR as it integrates imaging with therapy. Lack of ionizing radiation, improved target visualization with reduced risk of injury, and have a direct impact on patient care, eventually leading to improved quality of life.

Institutional environment and resources South West Finland Imaging centre is the diagnostic hub of Turku University hospital with 60 academic radiologists and supporting staff. Department of Oncology has extensive experience in oncological research and related imaging. The team headed by Docent Roberto Blanco Sequeiros has access to the scanning facilities that will be used in the project. South West Finland Imaging centre will provide the software development tools and computers required for the project. In addition, Prof. Heikki Minn, director of department of oncology is the main collaborator and Co-PI in the research. This will facilitate adequate patient selection and monitoring of research subjects. Close collaboration will be performed with Karolinska institutet where similar project is underway with the leadership of Professor Seppo Koskinen.

Ethical Considerations Corresponding ethical approval for the proposed clinical studies has been obtained from the ethical committee at Turku University Hospital, Turku. Clinical studies will start only after organizational permit is gained. Relevant patient information will be anonymized and protected in separate electronical storage which will be protected with encryption and researcher specific login data.

Funding The project has initial funding from the EVO-funding. Additional funding has been applied from the Swedish ALF- 2017 funding (Anslag forskning, utveckling och utbildning)

Potential participants are recruited by oncologist from oncology outpatient clinic. Pretreatment imaging with computer tomography and magnetic resonance imaging is performed to evaluate whether the patient is eligible for HIFU-treatment. Those eligible will continue to the treatment and unsuitable participants will continue in the study as a control group receiving radiation therapy.

Participants in these groups will have follow-up MRI:s, ct:s, laboratory exams and fill in VAS (visual analog scale) and health questionnaire SF-36 regularly. Also intake of pain medication will be followed.

MR Imaging- Guided High Intensity Focused Ultrasound (HIFU) Therapy of Bone Metastases

Possible collaboration in the future with Karolinska Institute, Stockholm, during later stages of the study when performing randomized experiments. Data to be shared would be MRI- and CT-data, laboratory results and health-questionnaire results.

Possible adverse effects found during treatment or in follow up will be collected and reported

Change in Visual analog scale pretreatment vs follow-up

Changes in tumor features pretreatment vs follow-up (signs of progression or regression)

Change in the use of strong opiate-based pain medication intake pretreatment vs follow-up

Change in SF-36 questionnaire pretreatment vs follow-up. SF36 is translated in finnish. It measures several variables related to quality of life ( eg mood, need of help)

Change in serum inflammatory cytokines pretreatment vs follow-up

Change in serum tumor-specific markers (eg. PSA for prostate cancer patients) pretreatment vs follow-up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ablation and Cementoplasty for Painful Bone Lesions	NCT04635137	Bone Lesion Bone Metastases Spine Metastase...	Ablation and Ce...	18 Years -	University of Calgary
Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis	NCT04310410	Bone Metastases Bone Neoplasm Bone Lesion Bone Cancer Pain Cancer Induced ... Radiation Toxic... Quality of Life Tumor Neoplasm Metast...	combined radiot...	18 Years -	UMC Utrecht
Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy	NCT05732558	Bone Lesion Bone Tumor Bone Infection	8 Patients who ...	18 Years -	R.A.W. - S.R.L.
Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy	NCT05732558	Bone Lesion Bone Tumor Bone Infection	8 Patients who ...	18 Years -	R.A.W. - S.R.L.
MR Imaging- Guided High Intensity Focused Ultrasound (HIFU) Therapy of Bone Metastases	NCT03106675	Bone Metastases Bone Neoplasm Bone Cancer Bone Lesion	Thermal ablatio... Varian Truebeam...	18 Years -	Turku University Hospital

Spots Global Cancer Trial Database for bone lesion

Every month we try and update this database with for bone lesion 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 bone lesion

Every month we try and update this database with for bone lesion 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 bone lesion 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.