Wen-Yen Chai1,2, Po-Chun Chun3, Sheng-Kai Wu4, Chih-Hung Tsai2, Hsin-Yi Lai5, and Hao-Li Liu2
1Department of Diagnostic Radiology and Intervention, Chang-Gung Memorial Hospital, Taoyuan, Taiwan, 2Department of Electrical Engineering, Chang-Gung University, Taoyuan, Taiwan, 3Department of Research and Development, NaviFUS corp., Taipei, Taiwan, 4Institute of Biomedical Engineering, National Taiwan University, Taipei, Taiwan, 5Interdisciplinary Institute of Neuroscience and Technology, Zhejiang University, Hangzhou, China
Synopsis
FUS exposure with
presence of microbubbles can transiently open the BBB at targeted brain tissues.
The study purpose is to investigate the dependency of the BBB opening effect with
ultrasound exposure time by DCE-MRI. Our result showed extending exposure time can
effectively increase FUS-induced BBB opening degree without causing tissue damage.
We also proposed a strategy by adjusting exposure time during the multiple
exposures to overcome the effects that microbubbles concentration dynamic
changed after IV bolus injection. This approach of control FUS exposure time
may bring technology advances of FUS-induced BBB opening to deliver drug for
CNS disease treatment.
Purpose
Focused ultrasound (FUS) exposure with intravascular
injection of microbubbles can transiently open the blood-brain barrier (BBB) at
targeted CNS tissue1-2. However, safety increase BBB opening scale
and persist BBB opening effect during microbubble concentration decay over time
in circulation are key
requirements of delivery of therapeutic molecules into the brain by FUS-induced
BBB opening. Our purpose is using DCE-MRI to further investigate the feasibility of increase and persist
BBB opening effect by adjust FUS exposure time in single or multiple exposures. Method
20 Sprague-Dawley rats were
used in this study. All rats were separated into five groups. Each Rat was
under isoflurane anesthesia first. 0.5 MHz focused
ultrasound transducers (diameter = 64 mm, radius of curvature = 63mm, duty cycle: 1%; PRF: 1 Hz) was used to transcranially single
and multiple exposures with 0.4 MPa (exposure level was chosen to avoid brain hemorrhage3) on hemisphere of rat.
Burst-tone mode ultrasound was delivered in five groups with 5 different exposure
time (single exposure: 1st group (15s), 2nd group (90s),
3rd group (120s); multiple exposures: 4th group (fixed 120s),
5th group (15s, 30s, 60s, 120s,) in the presence of ultrasound
microbubbles (Sonovue, Bracco). After exposure, Evans Blue (EB) was administrated
intravenously and rats were conducted MRI scan (7T, ClinScan, Bruker) for 10
mins. DCE T1-weighted imaging (3D FLASH T1 sequence, TE/TR = 0.76 ms/2.31 ms;
ST = 0.8 mm; FA = 5°/10°/15°/20°/25°/30°; matrix: 192 x 132) was performed to
evaluate the permeability of the opened BBB. Permeability was obtained based on
data post analysis using the Extended-Kety model4-6 to generate Ktrans
maps. In addition, Susceptibility-weighted imaging (SWI) sequences were acquired
to identify possible tissue hemorrhage associated with FUS-induced BBB opening.
All animals were sacrificed 2 hours after ultrasound exposure. EB concentration
quantitation7 and Hematoxylin eosin (H&E) were performed for
analysis.Result
Figure 1 showed a typical
comparison of the EB-stained brains and Ktrans map via DCE-MRI in
single exposure with 3 different exposure time. The EB-stained brains confirmed
the opening of the targeted BBB, and Ktrans which represented the
BBB-opened scale linearly correlated with the FUS exposure time (r2=0.9779).
Figure 2 showed the corresponding MR-SWI and HE stained examinations to confirm
absence of micro-intracerebral hemorrhage in FUS exposure time at 120s under
0.4MPa. Figure 3 showed the correlations of exposure time with quantitated
penetrated EB/Ktrans value under multiple FUS exposures by applying exposure-time
adjusting scheme. Figure 3(A), under fixed exposure time (120s), only first two
points were observed clearly BBB-opening induced by FUS in EB-stained brains
and Ktrans map (Ktrans: 1st point was 0.0097
min−1 and decay to 0.0029min−1 at the 4th point;
EB: 1st point was 0.65μm, and decay to 0.34μm at the 4th
point). When adjusting the exposure time, both EB-stained brains and Ktrans
map were observed clearly BBB-opening induced by FUS in 4 exposure points. Ktrans
value and EB concentration didn’t show sharp changes across all exposure points,
figure 3(B). (Ktrans: the 1st point
was 0.0062 min−1 and can be maintained to 0.0054min−1 at
the 4th point; EB: the 1st
point was measured to be 0.31μm, whereas the 4th point still
maintained to be 0.26μm; both p> 0.05). The detail values were summarized in
Table 1.Discussion
High correlation
between exposure time and Ktrans value in 0.62MI was observed,
implying that FUS exposure time is another capable parameters to increase FUS-BBB
opened scale except for increase MI. In addition, there is no erythrocyte
extravasations was observed when extend exposure time to 120s which mean
increase exposure time can not
only increase BBB permeability but also avoid brain hemorrhage (side effect of increase MPa ). However, microbubbles concentration will decay over time to decrease BBB
opening effect by FUS. But these is no significant decrease value of Ktrans
or EB concentration when multiple FUS exposures with adjusted exposure time
which implied geometrically increased exposure time successfully compensated
for the degradation of MB concentrations in circulation over time.Conclusion
This study demonstrated the alternate method to
effective increase FUS-induced BBB opening degree by extend FUS exposure time
under safety MPa and avoid brain hemorrhage. However, the microbubble concentration
will decay by the time in circulation. We also demonstrated the
adaptive exposure time can compensate for microbubble degradation
to produce a persistent BBB-opening effect by delivering multiple exposures to cover a large treatment region. This approach of control FUS exposure time
may bring technology advances and facilities the clinical application of
FUS-induced BBB opening to deliver therapeutic molecules for CNS disease
treatment.Acknowledgements
Tis work was supported by the Ministry of Science and Technology, TAIWAN, under grants nos 104-2221-E-182-034, 104-2221-E-182-034, 105-2221-E-182-022, 105-2221-E-182-022, 105-2923-B-002-001-MY3, and byChang Gung Memorial Hospital, TAIWAN, under grants nos CIRPD2E0051-53, CMRPD2D0111-13References
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