The main objective of the study was to prove the effectiveness of cryoablation in palliating pain and correlate the patients with a matched group of the Dutch bone metastasis study. The secondary objectives are to determine the accuracy of cryoprobe…
ID
Source
Brief title
Condition
- Synovial and bursal disorders
- Metastases
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Pain is a common symptom in cancer patients; up to 86% of the patients with
advanced cancer suffer from pain. Pain is caused by bone metastasis in 31% to
42% of these patients. Radiotherapy is the current palliative treatment
modality of choice in our hospital. This project has the goal to test the
feasibility of a novel focal treatment for these patients, namely CT/MR guided
cryoablation. Percutaneous cryoablation is a minimally invasive technique in
which freezing is used to destroy tissue. The freezing is seen on imaging as an
iceball. Cell death being reliable occurring 3mm deep near the edge. The
project combines three novel approaches implemented at our institution for
painful bone metastasis: MR techniques to identify the bone metastasis, CT/MR
guided cryoprobe(s) placement, and ablation under MR control.
A patient group of twenty patients will be included in this observational
study. We will include patients with no more than two painful bone metastasis.
The lesion must be osteolytic, not larger than 3 cm and it must be possible to
reach the lesion with 5 mm distance from the spinal cord, nerves, and artery of
Adamkiewicz.
The suggested technique holds the promise to provide an alternative treatment
for bone metastasis in our hospital, with less side effects to be expected
compared with radiation therapy (id est risk of a pathological fracture and
spinal cord compression). Potential complications will be recorded and the
response will be calculated considering changes in pain intensity.
The main objective of the study was to prove the effectiveness of cryoablation
in palliating pain and correlate the patients with a matched group of the Dutch
bone metastasis study. The secondary objectives are to determine the accuracy
of cryoprobe(s) placement under CT/MR guidance by measuring the 3D error at the
multimodality MR and CT/MR images retrospectively. And to correlate the MR
results from multimodality MR and the iceball on CT/MR imaging during the
ablation process with the pain control.
Study objective
The main objective of the study was to prove the effectiveness of cryoablation
in palliating pain and correlate the patients with a matched group of the Dutch
bone metastasis study. The secondary objectives are to determine the accuracy
of cryoprobe(s) placement under CT/MR guidance by measuring the 3D error at the
multimodality MR and CT/MR images retrospectively. And to correlate the MR
results from multimodality MR and the iceball on CT/MR imaging during the
ablation process with the pain control.
Study design
A prospective, observational non randomized study. This trial will be run at
the UMC St Radboud, 20 patients will be included at the UMC st Radboud from
October 2010 to October 2011.
Intervention
The patient group will undergo additional CT/MR guided cryoablation.
Study burden and risks
Potential patient risks in this study as mentioned by complications of MR
imaging (burden of heating and noise, risks of contrast reactions against
gadolinium), CT imaging (expected addition radiation cancer risk <0.02 Sv (see
K5), focal cryoablation (hemorrhage, inflammation) or serious unexpected events
and patient burden in form of time investment are outweighed by potential
benefits for patients.
Geert Grooteplein 10
6500HB Nijmegen
NL
Geert Grooteplein 10
6500HB Nijmegen
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33800.091.10 |