3 Tesla Magnetic Resonance Guided High Intensity Focused Ultrasound in the Treatment of Pain From Bone Metastases of Solid Tumors

• Status: Terminated
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve 3 Tesla MR-HIFU device for treating painful bone metastases.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Treatments: Analgesics

Criteria

Inclusion Criteria:

• Radiologic evidence of bone metastases (BM) from any solid tumors in patients with age ≥ 18 years

• Patient capable of giving informed consent and able to attend study visits

• All target lesion (s) at intended treatment site accessible for MR-HIFU Distance Skin-lesion (target) > 1 cm

• Patient has 1-3 painful lesions, and only the most painful lesion will be treated

• Weight < 140 Kg

• Intended target volume visible by non-contrast MRI

• Patient able to characterize pain at site of target lesion (s), before and after the procedure.

• MR-HIFU treatment date ≥ 2 weeks from last local treatment of the target lesion

Exclusion Criteria:

• Planned treatment lesion is a primary bone tumor Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment

• Unable to tolerate required stationary position during treatment

• Need for surgical stabilization in case of (impending) fracture (lytic lesion in weight-bearing bone larger than 50% of bone diameter)

• Pregnant woman

• Pain related to target lesion is predominantly due to fracture or impending fracture

• Pain related to target lesion is due to involvement of a neighboring major nerve by the metastatic tumor (cord or nerve compression)

• Target < 3cm from bladder / bowel / nerve along the beam path and < 1cm in the plane orthogonal to the beam

• Target in contact with hollow viscera

• Target located in skull, joints, ribs (when HIFU beam overlapping with lung), spine (excluding sacrum which is allowed) or sternum.

• Scar along proposed HIFU beam path

• Internal or external fixation device along the proposed HIFU beam path or at the target

• MRI contraindicated (e.g. paramagnetic implants, pacemaker, claustrophobia)

• MRI contrast agent contraindicated (e.g. previous anaphylaxis or glomerular filtration rate < 30 ml/min/1.73m2)

• Sedation contraindicated

• Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant as judged by the treating physician or investigator.