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Pilot Study for the Treatment of Bone Metastases by High Intensity Focused Ultrasound Guided by MRI to Perform Pain Palliation

Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Secondary Malignant Neoplasm of Bone

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Trial Information

Pilot Study for the Treatment of Bone Metastases by High Intensity Focused Ultrasound Guided by MRI to Perform Pain Palliation

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.

Inclusion Criteria:

- Men and women aged > 18 years

- Covered by social security insurance

- Patient able to give consent and able to attend

- study visit

- Weight < 140kg

- Patient with bone metastases

- Pain localized on bone metastases to be treated with NRS (0-10 scale) pain score
4 irrespective of medication

- Targeted tumor accessible for MR-HIFU treatment

- The maximum size of the bone metastases smaller than 8cm in diameter

- Targeted tumor visible by non contrast MRI

- Interface between bone and skin deeper than 10 mm

- Able to communicate sensation during treatment

- Treatment day must be planned at least 2 weeks after any treatment of the primary
tumor, chemotherapy or RT treatment of a bone targeted for HIFU

Exclusion Criteria:

- Person subject to a judicial safeguard order, subject participating in another
research study including an exclusion period which has not expired at the time of

- Patient enrolled in another clinical study related to bone metastases or pain relief

- Pregnant or nursing woman

- Need of surgical stabilization or site at risk of

- fracture

- More than one painful lesion per treatment

- Patients who are not able to tolerate required stationary position during treatment

- HIFU targeted tumor in contact with hollow viscera

- Targeted tumor less than 1 cm to nerve bundles, bladder and bowel

- Targeted tumor located in skull, spine (excepted sacrum) or sternum.

- MRI or contrast agent contraindicated

- Severe Cardiovascular, neurological, renal or hematological chronic disease

- Active infection

- Scar in the beam path

- Orthopedic implant at the site of treatment

- Previous surgery at the site of treatment Patient history, MRI exam

- Primary musculoskeletal malignancies, lymphoma, or leukemia

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Technical efficacy by medication and pain score

Outcome Description:

Technical efficacy of HIFU for treatment of bone metastasis as assessed by a change in the medication and pain scores

Outcome Time Frame:

0, 2, 7, 14, 30, 90 days

Safety Issue:


Principal Investigator

Hervé Trillaud, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital St. André, Service de Radiologie


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

May 2010

Completion Date:

October 2011

Related Keywords:

  • Secondary Malignant Neoplasm of Bone
  • bone metastasis
  • pain palliation
  • Bone Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Bone Marrow Diseases
  • Neoplasms, Second Primary