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CT/MR guided cryoablation for painful bone metastasis: an observational trial.

CT/MR guided cryoablation for painful bone metastasis: an observational trial. - nvt

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34458
Enrollment
20
Registered
2011-11-30
Start date
2010-12-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignancy metastases

Interventions

The patient group will undergo additional CT/MR guided cryoablation.

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)