Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT02718404
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02718404
Study Brief:
Protocol Section:
NCT02718404