A clinical treatment delivery platform has been developed and is being evaluated in a clinical pilot study for providing
3D controlled hyperthermia with catheter-based ultrasound applicators in conjunction with high dose rate (HDR)
brachytherapy. Catheter-based ultrasound applicators are capable of 3D spatial control of heating in both angle and
length of the devices, with enhanced radial penetration of heating compared to other hyperthermia technologies.
Interstitial and endocavity ultrasound devices have been developed specifically for applying hyperthermia within HDR
brachytherapy implants during radiation therapy in the treatment of cervix and prostate. A pilot study of the
combination of catheter based ultrasound with HDR brachytherapy for locally advanced prostate and cervical cancer has
been initiated, and preliminary results of the performance and heating distributions are reported herein. The treatment
delivery platform consists of a 32 channel RF amplifier and a 48 channel thermocouple monitoring system. Controlling
software can monitor and regulate frequency and power to each transducer section as required during the procedure.
Interstitial applicators consist of multiple transducer sections of 2-4 cm length × 180 deg and 3-4 cm × 360 deg. heating
patterns to be inserted in specific placed 13g implant catheters. The endocavity device, designed to be inserted within a
6 mm OD plastic tandem catheter within the cervix, consists of 2-3 transducers × dual 180 or 360 deg sectors. 3D
temperature based treatment planning and optimization is dovetailed to the HDR optimization based planning to best
configure and position the applicators within the catheters, and to determine optimal base power levels to each
transducer section. To date we have treated eight cervix implants and six prostate implants. 100 % of treatments
achieved a goal of >60 min duration, with therapeutic temperatures achieved in all cases. Thermal dosimetry within the
hyperthermia target volume (HTV) and clinical target volume (CTV) are reported. Catheter-based ultrasound
hyperthermia with HDR appears feasible with therapeutic temperature coverage of the target volume within the prostate
or cervix while sparing surrounding more sensitive regions.
A 3D optimization-based thermal treatment planning platform has been developed for the application of catheter-based
ultrasound hyperthermia in conjunction with high dose rate (HDR) brachytherapy for treating advanced pelvic tumors.
Optimal selection of applied power levels to each independently controlled transducer segment can be used to conform
and maximize therapeutic heating and thermal dose coverage to the target region, providing significant advantages over
current hyperthermia technology and improving treatment response. Critical anatomic structures, clinical target outlines,
and implant/applicator geometries were acquired from sequential multi-slice 2D images obtained from HDR treatment
planning and used to reconstruct patient specific 3D biothermal models. A constrained optimization algorithm was
devised and integrated within a finite element thermal solver to determine a priori the optimal applied power levels and
the resulting 3D temperature distributions such that therapeutic heating is maximized within the target, while placing
constraints on maximum tissue temperature and thermal exposure of surrounding non-targeted tissue. This optimizationbased
treatment planning and modeling system was applied on representative cases of clinical implants for HDR
treatment of cervix and prostate to evaluate the utility of this planning approach. The planning provided significant
improvement in achievable temperature distributions for all cases, with substantial increase in T90 and thermal dose
(CEM43T90) coverage to the hyperthermia target volume while decreasing maximum treatment temperature and reducing
thermal dose exposure to surrounding non-targeted tissues and thermally sensitive rectum and bladder. This
optimization based treatment planning platform with catheter-based ultrasound applicators is a useful tool that has
potential to significantly improve the delivery of hyperthermia in conjunction with HDR brachytherapy. The planning
platform has been extended to model thermal ablation, including the addition of temperature dependent attenuation,
perfusion, and tissue damage. Pilot point control at the target boundaries was implemented to control power delivery to
each transducer section, simulating an approach feasible for MR guided procedures. The computer model of thermal
ablation was evaluated on representative patient anatomies to demonstrate the feasibility of using catheter-based
ultrasound thermal ablation for treatment of benign prostate hyperplasia (BPH) and prostate cancer, and to assist in
designing applicators and treatment delivery strategies.
KEYWORDS: Francium, Ultrasonography, Thermometry, Amplifiers, Control systems, Transducers, High dynamic range imaging, Computing systems, Temperature metrology, Human-machine interfaces
A clinical treatment delivery platform has been developed for providing 3D controlled hyperthermia with catheter-based
ultrasound applicators in conjunction with high dose rate (HDR) brachytherapy. This integrated system consists of
hardware and software components required for thermal therapy delivery, treatment monitoring and control, and realtime
and post-treatment analysis; and interstitial and endocavity ultrasound heating applicators. Hardware includes a
32-channel RF amplifier with independent power (0-25 W) and frequency (5-10 MHz) control for ultrasound power
delivery and a 48-channel thermometry system compatible with 0.4 mm OD multi-sensor thermocouple probes.
Software graphical user interfaces (GUI) are used to monitor and control both the amplifier and the thermometry system.
The amplifier GUI controls, monitors, and records individual channel frequency and power values in real-time; the
thermometry GUI monitors and records temperature and thermal dose values in real-time, as well as displaying and
allowing dynamic control for temperature and thermal dose target thresholds. The thermometry GUI also incorporates
registration of thermocouple positions relative to target anatomy and applicator transducers based on HDR planning
tools (CT/MRI/US overlays) for improved treatment control and documentation. The interstitial (2.4 mm) and
endocavity (6 mm) ultrasound hyperthermia applicators are composed of linear arrays of 1-4 tubular piezoceramic
transducers - sectored at 90°, 180°, 270°, and 360° for single or dual directional heating patterns - that are compatible
with plastic implant catheters. QA techniques specific to these catheter-based ultrasound applicators have been devised
and implemented, and include rotational beam plots and dynamic force balance efficiency measurements, which are
critical to establish applicator performance. A quality assurance test matrix has been devised and used to evaluate and
characterize all components of this system prior to clinical implementation.
An intracavitary hyperthermia applicator for targeted heat delivery to the cervix was developed based on a linear array of
sectored tubular ultrasound transducers that provides truly 3-D heating control (angular and along the length). A central
conduit can incorporate an HDR source for sequential or simultaneous delivery of heat and radiation. Hyperthermia
treatment volumes were determined from brachytherapy treatment planning data and used as a basis for biothermal
simulations analyzing the effects of device parameters, tissue properties, and catheter materials on heating patterns.
Devices were then developed with 1-3 elements at 6.5-8 MHz with
90-180° sectors and a 15-35 mm heating length,
housed within a 6-mm diameter water-cooled PET catheter. Directional heating from sectored transducers could extend
lateral penetration of therapeutic heating (41°C) >2 cm while maintaining rectum and bladder temperatures within 12
mm below thermal damage thresholds. Imaging artifacts were evaluated with standard CT, cone beam CT, and MR
images. MR thermal imaging was used to demonstrate shaping of heating profiles in axial and coronal slices with
artifact <2 mm from the device. The impact of the high-Z applicator materials on the HDR dose distribution was
assessed using a well-type ionization chamber and was found to be less than 6% attenuation, which can readily be
accounted for with treatment planning software. The intrauterine ultrasound device has demonstrated potential for 3-D
conformal heating of clinical tumors in the delivery of targeted hyperthermia in conjunction with brachytherapy to the
cervix.
Four types of transurethral applicators were devised for thermal ablation of prostate combined with MR thermal
monitoring: sectored tubular transducer devices with directional heating patterns; planar and curvilinear devices with
narrow heating patterns; and multi-sectored tubular devices capable of dynamic angular control without applicator
movement. These devices are integrated with a 4 mm delivery catheter, incorporate an inflatable cooling balloon (10
mm OD) for positioning within the prostate and capable of rotation via an MR-compatible motor. Interstitial devices
(2.4 mm OD) have been developed for percutaneous implantation with directional or dynamic angular control. In vivo
experiments in canine prostate under MR temperature imaging were used to evaluate the heating technology and develop
treatment control strategies. MR thermal imaging in a 0.5 T interventional MRI was used to monitor temperature and
thermal dose in multiple slices through the target volume. Sectored tubular, planar, and curvilinear transurethral
devices produce directional coagulation zones, extending 15-20 mm radial distance to the outer prostate capsule.
Sequential rotation and modulated dwell time can conform thermal ablation to selected regions. Multi-sectored
transurethral applicators can dynamically control the angular heating profile and target large regions of the gland in short
treatment times without applicator manipulation. Interstitial implants with directional devices can be used to effectively
ablate the posterior peripheral zone of the gland while protecting the rectum. The MR derived 52 °C and lethal thermal
dose contours (t43=240 min) allowed for real-time control of the applicators and effectively defined the extent of thermal
damage. Catheter-based ultrasound devices, combined with MR thermal monitoring, can produce relatively fast and
precise thermal ablation of prostate, with potential for treatment of cancer or BPH.
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