Secondary Malignant Neoplasm of Bone Clinical Trial
Official title:
Pilot Study for the Treatment of Bone Metastases by High Intensity Focused Ultrasound Guided by MRI to Perform Pain Palliation
This study is to confirm the safety and technical of MRI guided High Intensity Focused
Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases.
MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate
tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue.
The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be
performed in patients who pass inclusion/exclusion criteria.
Bone is the third most common site of metastases spread after the liver and the lungs, with
a great incidence in breast, prostate, lung, kidney and thyroid cancers. For example, 90% of
patients dying from breast cancer and most of patients with advanced prostate cancer suffer
from bone metastases, which are frequently responsible of chronic pain and lead to an
increase in morbidity and mortality with pathological fractures, compression syndrome and
hypercalcemia..Moreover, the increasing longevity of patients with cancer resulting from the
improvement of the effectiveness of the treatments leads to a higher incidence and
prevalence of metastating bone lesions.
Palliative treatment with management of pain and improvement of quality of life remains the
first goal of therapy. Current treatments options include systemic drug therapy
(chemotherapy, hormonal therapy, analgesics and bi-phosphonates), local invasive treatment
(surgery), local mini-invasive treatment with interventional radiological techniques
(cimentoplasty, cryotherapy and radiofrequency ablation) and radiation therapy.
External-beam radiation therapy remains the current standard of care for patients with bone
metastases in first intention. However, up to 20-30 % of patients treated do not experience
pain relief and recurrence of pain appear in 27 % after treatment. Moreover radiation
treatment is limited due to accumulation of dose. Since few years, cryotherapy and
percutaneous radiofrequency ablation have shown good results in management of pain with bone
metastases, however these techniques are still invasive.
In MRI-guided High Intensity Focused Ultrasound (HIFU), the ultrasound generated by the
transducer is focused into a small focal tissue volume at specific target locations. During
treatment, the beam of focused ultrasound energy penetrates through soft tissue and causes
localized temperatures elevation up 55-70°C for a few seconds within the target producing
well defined regions of irreversible protein denaturation, cell damage, and coagulative
necrosis. A single exposure of focused ultrasound energy is called a "sonication." Multiple
sonications are necessary to ablate the targeted tissue. Tight focusing is designed to limit
the ablation to the targeted location.
Applying HIFU energy to a patient's lesion requires treatment planning, targeting of the
ultrasound (US) beam to desired locations and monitoring of the energy delivery. In some
applications this can be performed using diagnostic ultrasound imaging in combination with
the HIFU. While diagnostic US provides some anatomical details and helps with procedure
planning and treatment targeting, it does not provide 3D planning, means of measuring the
temperature increase generated by HIFU, or metrics for quantifying the energy/dose delivered
to the treatment zone. Currently, only MR imaging can provide a validated non-invasive
temperature measurement and thermal dose quantification in the treated tissue. Furthermore,
these real-time MR temperature measurements can be used to control the HIFU system to
deliver optimal temperatures to the target locations. The Philips MR-guided focused
ultrasound system will provide real-time tissue temperature mapping in multiple planes and
control of the temperature delivering dose to the target location. Recent advances in MR
temperature mapping make it possible to achieve temperature accuracy of 1°C in stationary
soft tissues.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02887833 -
Thermal Testing in Bone Pain (TiBoP)
|
||
| Enrolling by invitation |
NCT01693770 -
Primary Pain Palliation in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
|
Phase 1/Phase 2 |