Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02718404 : 3 Tesla Magnetic Resonance Guided High Intensity Focused Ultrasound in the Treatment of Pain From Bone Metastases of Solid Tumors
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02718404      |      Link to official Clinicaltrials.gov listing
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