The PRE-FURTHER project aims to evaluate the feasibility of the combined EBRT and MR-HIFU treatment for relief of metastatic bone pain, and to optimize the combined treatment logistics.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Metastases
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome of this study is feasibility of the procedure, in terms of
plannability as well as patient-tolerability of the combined treatment within a
short time frame (3 hours - 4 days interval).
Secondary outcome
In addition, pain relief and safety of the combined procedure will be
monitored.
Background summary
Magnetic Resonance Image guided High-Intensity Focused Ultrasound (MR-HIFU) is
a non-invasive technique, which may induce rapid induction of pain relief in
patients with painful bone metastases. In 2019, an international, H2020 funded
randomized controlled trial (FURTHER) will be started comparing MR-HIFU with
the current standard of care, external beam radiotherapy (EBRT), and the
combination of both modalities in terms of rapid and long lasting pain relief.
For this purpose, feasibility and optimal logistics of the combined treatment
need to be evaluated.
Study objective
The PRE-FURTHER project aims to evaluate the feasibility of the combined EBRT
and MR-HIFU treatment for relief of metastatic bone pain, and to optimize the
combined treatment logistics.
Study design
Prospective case series (n = 6 - 10), stage I and IIA study according to the
Innovation, Development, Evaluation, Assessment and Long term evaluation
(IDEAL) recommendations.
Intervention
Following standard EBRT (single or multiple fraction), patients will receive
one MR-HIFU treatment with the Profound Sonalleve MR-HIFU device on the most
painful of their bone metastases. Patients will be followed up until 4 weeks
after treatment. During follow-up they will be phoned around day 3, 7, 14, 21
and 28 to retrieve pain scores, pain medication and (serious) adverse events.
At day 3 the patient*s experience with the combined treatment will also be
inquired.
Study burden and risks
In terms of benefits, patients participating in this study may experience a
more rapid and longer lasting pain relief as a result of the MR-HIFU
intervention. In terms of burden, patients in most cases will need to pay an
extra visit to the hospital, undergo a rather lengthy additional intervention
(MR-HIFU treatment), under conscious sedation. In addition, they are contacted
regularly by phone. Serious adverse events due to the combined treatment are
not to be expected.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Men and women with age * 18 years;
- Patient capable of giving informed consent and able to attend study visits;
- Uncomplicated painful bone metastases;
- Weight < 140kg and able to fit in the MRI gantry;
- Radiologic evidence of bone metastases from any solid tumor;
- Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area;
- Pain related to the target lesion is refractory to less invasive treatments for pain relief;
- Multiple metastatic lesions, with one predominantly painful lesion (><=2 points higher pain score than other lesions). The lesion should be clearly distinguishable form other painful lesions;
- Device accessible tumors: extremities (excluding joints), pelvis, shoulders, posterior vertebral spine below L5, in selected cases ribs and sternum;
- Target lesion maximum dimension * 8cm;
- Intended target volume visible by non-contrast MR imaging;
- Distance between target and skin * 1cm;
- Numeric Rating Scale (NRS) score ><= 4 or equivalent;
- Life expectancy >3 months.
Exclusion criteria
- Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, 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 despite adequate pain medication;
- Need for surgery;
- 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;
- 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 < 20 ml/min/1.73m2);
- Sedation contraindicated;
- Previous surgery or minimally invasive treatment at targeted site within the last three months;
- 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;
- Karnofsky performance score (KPS) < 60%;
- Oligometastatic disease planned for curative treatment;
- Indication for stereotactic radiotherapy (e.g. patients with radioresistent histology such as renal cell, melanoma, sarcoma metastases);
- History of photodermatoses (of the skin overlying the target area);
- Need for remineralisation;
- Previous radiation to same site.
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 |
|---|---|
| CCMO | NL68441.041.19 |