MR Imaging- Guided High Intensity Focused Ultrasound (HIFU) Therapy of Bone Metastases
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|ClinicalTrials.gov Identifier: NCT03106675|
Recruitment Status : Not yet recruiting
First Posted : April 10, 2017
Last Update Posted : April 24, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastases Bone Neoplasm Bone Cancer Bone Lesion||Device: Thermal ablation of bone metastasis with MR-HIFU device Philips Sonalleve coupled with Philips Ingenia 3.0T Device: Varian Truebeam Radiotherapy System||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
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.
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||MR Imaging- Guided High Intensity Focused Ultrasound (HIFU) Therapy of Bone Metastases|
|Estimated Study Start Date :||May 15, 2017|
|Estimated Primary Completion Date :||January 30, 2022|
|Estimated Study Completion Date :||March 30, 2022|
Device: Thermal ablation of bone metastasis with MR-HIFU device Philips Sonalleve coupled with Philips Ingenia 3.0T
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.
Other Name: Sonalleve product number 781360.
Active Comparator: Radiation therapy
Device: Varian Truebeam Radiotherapy System
Conventional radiotherapy focused on bone tumor. Pretreatment planning images acquired with computer tomography
- Change in subjective pain relieve [ Time Frame: 6 months ]Change in Visual analog scale pretreatment vs follow-up
- Change in tumor morphology in imaging [ Time Frame: 6 months ]Changes in tumor features pretreatment vs follow-up (signs of progression or regression)
- Change in pain medication usage [ Time Frame: 6 months ]Change in the use of strong opiate-based pain medication intake pretreatment vs follow-up
- Change in general subjective health [ Time Frame: 6 months ]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 cytokine-levels [ Time Frame: 1 month ]Change in serum inflammatory cytokines pretreatment vs follow-up
- Change in tumor-specific markers [ Time Frame: 1 month ]Change in serum tumor-specific markers (eg. PSA for prostate cancer patients) pretreatment vs follow-up
- Adverse effects [ Time Frame: 6 months ]Possible adverse effects found during treatment or in follow up will be collected and reported
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): NCT03106675
|Contact: Roberto T Blanco Sequeiros, Dosent, MDemail@example.com|
|Contact: Heikki E Pärssinen, MD, PhD Studentfirstname.lastname@example.org|
|Study Director:||Gaber Komar, PhD, MD||TYKS/VSKK (Turku University Hospital / Proper Finlands Imaging center)|
|Principal Investigator:||Mira Huhtala, MD, PhD student||TYKS Oncology (Turku University Hospital)|
|Study Director:||Heikki Minn, Professor, MD||TYKS Oncology|
|Principal Investigator:||Teija O Sainio, MSc, PhD Student||TYKS/VSKK (Turku University Hospital / Proper Finlands Imaging center)|