Clinical Trials in Radiology
Insights Imaging
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Clinical Trials in Radiology (CT)
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Wednesday, February 28
Purpose: Purpose: to examine the clinical outcome of MR-guided focused
ultrasound (MRgFUS) and external-beam radiation therapy (EBRT) in patients
with painful bone metastasis.
Ethics committee approval: This study received institutional ethics committee
approval. All patients provided written informed consent.
Methods and Materials: Patients with solid tumors and one or more bone
metastasis were included. Eligible patients were 18years of age, had
radiologically-proven bone metastasis, could safely undergo both MRgFUS
and radiotherapy and had pain scores 4(on 0-to-10 numeric rating scale).
Participants were randomly assigned (1:1 ratio) to receive MRgFUS or EBRT.
The primary endpoint was treatment response, defined as a reduction of
2points in worst pain by week-4, accompanied by a stable or reduced opioid
dose, compared with baseline. Secondary endpoints assessed average pain,
interference of pain with activities, breakthrough pain, mood, quality of life, and
adverse events.
Results: 233 patients (M:125,F:108) were enrolled and randomly assigned to
MRgFUS(116) and EBRT(117). In the MRgFUS arm, 90 patients(77.6%)
achieved the primary endpoint, compared with 92(78.6%) in the EBRT arm
(adjusted odds ratio, 1.07;p=0.818). There were no significant differences in
average pain, pain interference with activity, breakthrough pain, mood and
quality of life between arms.
Limitations: This work only considers short-term results, assessing primary
and secondary outcomes within the first month after treatment.
Conclusion: The role of MRgFUS in cancer-induced bone pain is comparable
to EBRT, with the advantage of radiation-free and single-session procedure.
MRgFUS is limited to non-spinal locations.
Funding for this study: This study was conducted without any direct
founding.
Purpose: To evaluate the clinical benefit of using an electromagnetic
navigation system during CT-guided interventional radiology procedures.
Ethics committee approval: French Sud-Est V ethical committee
(12/06/2013).
Methods and Materials: This study included 455 patients between December
2013 and July 2015 across nine participating hospitals. After randomization,
percutaneous procedures were carried out either under conventional CT
guidance (CT group), or using the additional assistance of IMACTIS-CT®
navigation system (NAV group). The primary outcome was evaluated by a
blinded expert committee. It assessed the safety (number of serious adverse
events), efficiency (number of targets reached) and performance (number of
CT control acquisitions required to reach the target) of CT-guided
interventions.
Results: All patients (227 patients in NAV group and 228 patients in CT group)
were included in the intention-to-treat analysis. Missing data of 4 patients were
re-coded according to a worst-case scheme in disfavor of navigation. In
noninferiority analysis, NAV system was as safe (CI90 [-0.03;0.032]; c=0.07) and
as efficient (CI90 [-0.03;0.008]; - c=-0.1) as conventional guidance. The
number of CT control demonstrated to be reduced using NAV (5[3;9]) vs CT
(6[3;11]) p=0.015.
Limitations: For 38 patients, the intervention was only partially achieved
according to the initially randomized protocol: in most cases (33/38), radiologist
went back to CT instead of NAV protocol, because of respiratory movements
and/or lack of experience with the navigation system
Conclusion: The use of an electromagnetic navigation system allows to reach
the targets with fewer CT control acquisitions than with conventional CT
guidance.
Funding for this study: French Ministry of Health.
Author Disclosures:
I. Bricault: Advisory Board; member of the scientific advisory board of Imactis.
11:10
Discussant
T. Penzkofer; Berlin/DE
B-0187 11:15
Randomised clinical trial of portal vein embolisation using n-butylcyanoacrylate vs polyvinyl alcohol particles plus coils for liver hypertrophy before major hepatectomies
J.H.M. Luz1, E. Coimbra1, T. Bilhim1, F.V. Gomes1, N.V. Costa1, M.T. Correia1,
P. Luz2, E. Barroso1; 1Lisbon/PT, 2Rio de Janeiro/BR ()
Purpose: The aim of this study is to compare the efficacy of portal vein
embolisation (PVE) using n-butyl-cyanoacrylate (NBCA) versus polyvinyl
alcohol (PVA) particles plus coils in the induction of liver hypertrophy before
major hepatectomies.
Ethics committee approval: The hospital review board and local ethics
committee approved the study protocol.
Methods and Materials: This is a randomised clinical trial, single site. Eighty
consecutive patients with resectable liver tumors and indication for
preoperative PVE are randomised for one of two arms (40 patients in each
arm). Primary endpoint is to compare the degree of hepatic hypertrophy,
through computed tomography volumetry, at 14 and 28 days after PVE.
Secondary endpoints are the comparative analysis of the two PVE methods
(complications, cost, procedure time, contrast usage and r (...truncated)