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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
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

Brief Summary:

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
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIFU-treatment
  • 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
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
  • 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
Device: Varian Truebeam Radiotherapy System
Conventional radiotherapy focused on bone tumor. Pretreatment planning images acquired with computer tomography




Primary Outcome Measures :
  1. Change in subjective pain relieve [ Time Frame: 6 months ]
    Change in Visual analog scale pretreatment vs follow-up


Secondary Outcome Measures :
  1. Change in tumor morphology in imaging [ Time Frame: 6 months ]
    Changes in tumor features pretreatment vs follow-up (signs of progression or regression)

  2. Change in pain medication usage [ Time Frame: 6 months ]
    Change in the use of strong opiate-based pain medication intake pretreatment vs follow-up

  3. 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)

  4. Change in cytokine-levels [ Time Frame: 1 month ]
    Change in serum inflammatory cytokines pretreatment vs follow-up

  5. 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


Other Outcome Measures:
  1. Adverse effects [ Time Frame: 6 months ]
    Possible adverse effects found during treatment or in follow up will be collected and reported



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Bone metastasis
  • Maximum three metastasis to be treated
  • Pain that clearly locates to certain metastatic lesion
  • Intolerable pain regardless of radiotherapy and adequate pain medication

Exclusion criteria from HIFU-treatment group

  • ASA-group III or higher or anesthesia during procedure is required
  • Metastasis not safely reachable with HIFU

Exclusion criteria from the study

- Diffusely spread metastasis on bone


Information from the National Library of Medicine

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


Contacts
Contact: Roberto T Blanco Sequeiros, Dosent, MD +358445922092 roberto.blanco@tyks.fi
Contact: Heikki E Pärssinen, MD, PhD Student +358405018739 heikki.parssinen@tyks.fi

Sponsors and Collaborators
Turku University Hospital
Investigators
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)

Publications:
Jolesz FA, Silverman SG. Interventional magnetic resonance therapy. Semin Intervent Radiol 1995;12: 20-2
Kettenbach J, Kuroda K, Hata N, Morrison P, McDannold NJ, et al. Laserinduced thermotherapy of cerebral neoplasia under MR tomographic control. Min. Invas. Ther. Allied Technol. 1998; 7/6:589- 98
Kuroda K, Abe K, Tsutsumi S, Ishihara Y, Suzuki Y, Sato K. Water proton magnetic resonance spectroscopic imaging. Biomed Thermol 1993;13:43 - 62.
Hindman JC. Proton resonance shift of water in the gas and liquid states. J Chem Phys 1966;44:4582 - 92.

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT03106675     History of Changes
Other Study ID Numbers: 133/2016
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Turku University Hospital:
HIFU
MR-HIFU
MRgFUs
MRI-intervention
Palliation

Additional relevant MeSH terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Osteosarcoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma