CT/MR guided cryoablation for painful bone metastasis: an observational trial.
- Conditions
- 1002747610005944malignancymetastases10013361
- Registration Number
- NL-OMON34458
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
• 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The feasibility of CT/MR guided cryoablation in vivo in patients with painful<br /><br>bone metastasis is described by changes in pain intensity. These results will<br /><br>be correlated with a matched group of the Dutch bone metastasis study; the<br /><br>endpoint is response to pain. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The accuracy of cryoprobe(s) placement under CT/MR image guidance is given by<br /><br>measuring the 3D error at the images retrospectively. The correlation between<br /><br>the MR results from multimodality MR and the CT/MR imaging will be compared<br /><br>with the clinical results.</p><br>