NCT03106675

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

Status unknown NA Last updated 24 April 2017

What this trial tests

NA trial testing Thermal ablation of bone metastasis with MR-HIFU device Philips Sonalleve coupled with Philips Ingenia 3.0T in Bone Metastases in 30 participants. Status unknown.

Timeline

15 May 2017

Primary endpoint
30 January 2022

30 March 2022

Quick facts

Lead sponsor	Turku University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	15 May 2017
Primary completion	30 January 2022
Estimated completion	30 March 2022

Drugs / interventions tested

• Thermal ablation of bone metastasis with MR-HIFU device Philips Sonalleve coupled with Philips Ingenia 3.0T
• Varian Truebeam Radiotherapy System

Conditions studied

• Bone Metastases — all drugs for Bone Metastases →
• Bone Neoplasm — all drugs for Bone Neoplasm →
• Bone Cancer — all drugs for Bone Cancer →
• Bone Lesion — all drugs for Bone Lesion →

Sponsor

Turku University Hospital

Who can join

18 and older, any sex, with Bone Metastases or Bone Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current concepts in bone metastasis, contemporary therapeutic strategies and ongoing clinical trials.
   Gdowski AS, Ranjan A, Vishwanatha JK. · · 2017 · cited 83× · PMID 28800754 · DOI 10.1186/s13046-017-0578-1
2. Recent Advances in the Treatment of Bone Metastases and Primary Bone Tumors: An Up-to-Date Review.
   Bădilă AE, Rădulescu DM, Niculescu AG, Grumezescu AM, et al · · 2021 · cited 62× · PMID 34439383 · DOI 10.3390/cancers13164229
3. Immunomodulation and targeted drug delivery with high intensity focused ultrasound (HIFU): Principles and mechanisms.
   Ashar H, Ranjan A. · · 2023 · cited 41× · PMID 36965581 · DOI 10.1016/j.pharmthera.2023.108393
4. Focused Ultrasound (FUS) for Chronic Pain Management: Approved and Potential Applications.
   di Biase L, Falato E, Caminiti ML, Pecoraro PM, et al · · 2021 · cited 37× · PMID 34258062 · DOI 10.1155/2021/8438498