malignancy metastases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • 18 years of age or more • Histologically proven malignancy • Signed informed consent by patient • Pain intensity of at least 2. [18] • Lesion must be osteolytic • Lesion should be reachable, with a distance of 5 mm of the spinal cord, nerves, braines and artery of Adamkiewicz. • Bone metastasis smaller than 3 cm.
Exclusion criteria
Exclusion criteria: • Patients unable to undergo MR imaging, including those with contra-indications • Any metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging • Metastases of malignant melanoma or renal cell carcinoma because these are considered to express a different biological behaviour. • Metastases in the cervical spine because it is believed that large fractions might lead to a radiation induced myelopathy and thus cannot be compared with the matched group. • Adult with more than two painful bone metastasis • Previous treatment for painful bone metastasis • Metastases that need stabilization with cementoplasty.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of CT/MR guided cryoablation in vivo in patients with painful bone metastasis is described by changes in pain intensity. These results will be correlated with a matched group of the Dutch bone metastasis study; the endpoint is response to pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| The accuracy of cryoprobe(s) placement under CT/MR image guidance is given by measuring the 3D error at the images retrospectively. The correlation between the MR results from multimodality MR and the CT/MR imaging will be compared with the clinical results. | — |
Countries
Netherlands