NL-OMON34458
Not Yet Recruiting
Phase 2
CT/MR guided cryoablation for painful bone metastasis: an observational trial. - nvt
niversitair Medisch Centrum Sint Radboud0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- malignancy
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 20
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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