The primary objective of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device for the palliation of pain in patients with bone metastases.
ID
Source
Brief title
Condition
- Bone and joint injuries
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the pain response (dichotomous outcome) 30 days
after treatment. Pain response is determined by comparing pain score (NRS) and
pain medication at 30 days after treatment with baseline values in the same
patient.
Secondary outcome
Incidence of adverse events.
Quality-of-life.
Time-related aspects of pain response.
Changes in size/enhancement pattern on x-ray and MRI.
Background summary
Metastatic bone pain occurs frequently in cancer patients. In addition to pain
medication, radiotherapy is the standard of care for palliative treatment of
metastatic bone pain. In around 30-40% of patients no pain response occurs
after radiotherapy. Recurrence is also common (around 50%) after initial
response to radiotherapy. Reirradiation is not always possible due to dose
accumulation, and when applied response occurs in around 60%.
Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU)
is a new palliative treatment for metastatic bone pain. In this treatment
ultrasound is used to locally heat tissue under MRI-guidance. The main
mechanism is thought to be local bone denervation, caused by the heat
denaturation of the periosteum. The importance of this therapy is that it
offers a non-invasive, focal therapy, avoiding side-effects to surrounding
normal tissue or the need for needle insertion as with RF ablation.
The null hypothesis is that 40% of patients will exhibit pain response (partial
or complete response) at 30 days after treatment (assuming MR-HIFU is not
effective). The alternative hypothesis is that > 60% of patients will exhibit
pain response at 30 days after treatment.
Study objective
The primary objective of this study is to evaluate effectiveness of the Philips
Sonalleve MR-HIFU device for the palliation of pain in patients with bone
metastases.
Study design
This study is a multi-center, single arm, non-randomized, non-blinded trial.
Intervention
All patients will receive one session of MR-HIFU treatment with the Philips
Sonalleve MR-HIFU device on the most painful bone metastasis.
Study burden and risks
Patients will be required to attend up to seven site visits. The total duration
of the study for a single patient will be around four months, including the
time required for informed consent and screening and a follow-up period of up
to 90 days.
The first 30 days after treatment patients are asked to keep a diary in which
the pain scores and pain medication is required. In addition, they will be
asked to complete questionnaires (about pain and quality of life) on up to six
occasions. Up to five clinical examinations will be performed and one blood
sample will be taken. Patients will undergo five MRI scans, four x-ray images
and one CT scan. The radiation exposure is considered acceptable since this is
relatively low and the patients that will be treated do not have a long life
expectancy in general. During MR-HIFU treatment there is a risk of increased
temporary pain. The pain medication and/or sedation will be adjusted
accordingly.
Patients will probably experience partial or total relief from the pain arising
from the targeted metastasis. Furthermore, patients enrolling in this study
will help determine the efficacy and safety of a new non-invasion therapy for
pain palliation in bone metastases.
It is deemed that the potential benefits of this study, both to the individual
patient, as manifested by potential pain relief at the targeted lesion, and to
the wider patient community, as manifested by potential wider availability of a
non-invasive option for pain palliation in bone metastases, outweighs the
potential risks.
Äyritie 4
Vantaa FI-01510
FI
Äyritie 4
Vantaa FI-01510
FI
Listed location countries
Age
Inclusion criteria
Men and women with age * 18 years.
Capable of giving informed consent and able to attend study visits.
Weight < 140 kg.
Radiologic evidence of bone metastases from any solid tumor.
Diagnosis of dominant painful bone metastasis (NRS * 4), either refractory to standard of care (including radiotherapy and optimal pain medication) or standard of care is refused by patient or contra-indicated.
Patient has been on stable pain medication for at least 1 week prior to HIFU treatment date.
Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area.
Patient has 1-3 painful lesions, and only the most painful lesion will be treated.
Intended Target Volume accessible for MR-HIFU procedure.
Target lesion maximum dimension * 8 cm.
Intended target volume visible by non-contrast MR imaging.
Distance between target and skin * 1 cm.
Patient is able to communicate sensation during MR-HIFU treatment.
MR-HIFU treatment date * 4 weeks from last local treatment of the target lesion.
Exclusion criteria
Planned treatment lesion is a primary bone tumor or due to lymphoma or leukemia.
Communication barrier present.
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 < 3 cm from bladder / bowel / nerve along the beam path and < 1 cm 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 GFR < 30 ml/min/1.73m2).
Sedation contraindicated.
Previous surgery or minimally invasive treatment at targeted site.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01586273 |
| CCMO | NL39330.041.12 |