What is Hyperthermia?
Hyperthermia – heating the tumor to 40-45
°C – combined with radiation and/or
chemotherapy
is a proven treatment for malignant tumors.
Randomized clinical trials show that combining
hyperthermia with other therapies improved
disease free survival and local tumor control
without an increase in toxicity.
ISO & CE certified
ISO 9001:2000
ISO 13485:2003
BSD-2000 Function & Operations
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What is Deep Regional
Hyperthermia?
Deep regional hyperthermia
provides therapeutic
heating to deep-seated tumors that are located
more than 3 cm under the skin surface. Focused
electromagnetic energy radiated at about
100 MHz (radio frequency) raises the
temperature of the tumor region to therapeutic
temperatures. The radio frequency power can
be adjusted in amplitude and phase to conform
the
heating pattern to the tumor shape and size.
Several different applicators are available
for treating various tumor locations.
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Hyperthermia
and Chemotherapy
For cytostatic drugs, hyperthermia
used in combination with chemotherapy will increase
the concentration of the drug in the tumor region
because of the increased blood flow caused by
heat. In addition, hyperthermia has demonstrated
the ability to enhance drug toxicity in cells
resistant to many drugs. Hyperthermia can be employed
synergistically with chemotherapy in strategies
to treat high-risk tumors with the intent to cure.
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Hyperthermia
and Radiotherapy
The combination of hyperthermia
and
radiotherapy increases the effectiveness of radiotherapy
alone. Hyperthermic temperatures increase blood
circulation in tumors as a response to the stimulus
of heat. Tumor tissues that have low blood flow
are resistant to radiotherapy but are sensitive
to hyperthermia, while tumor tissues with high
blood flow are sensitive to radiotherapy. This
highly complementary interaction is a compelling
reason for combining hyperthermia and ionizing
radiation. |
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Pelvic Tumors
(Cervix/ Rectal/Bladder)
Complete-response rates
were 39% after radiotherapy and 55% after radiotherapy
plus hyperthermia. The duration of local control
was significantly longer with radiotherapy plus
hyperthermia than with radiotherapy alone. 3-year
overall survival was 27% in the radiotherapy
group and 51% in the radiotherapy plus hyperthermia
group.
The Lancet 2000,
Vol. 355: 1119 - 1125
Prostate Cancer
patients with symptomatic,
locally advanced, previously irradiated hormone
refractory prostate cancer were treated with
further radiation and external hyperthermia.
All patients had complete resolution of symptoms
lasting for 12-24 months.
At most recent follow-up, no patient has experienced
significant treatment-related side effects.
In these patients with no other therapeutic
alternatives, re-irradiation and hyperthermia
can provide durable tumor response for more
than a year, resulting in significant improvement
in quality of life.
The British
Journal of Radiology 2001, Vol. 74: 745 - 751
Soft Tissue Sarcomas
Response to neoadjuvant chemotherapy combined
with regional hyperthermia is predictive for
an improved local tumor
control resulting in a long-term survival benefit
for patients with high-risk soft
tissue sarcomas at unfavorable retro-
peritoneal or visceral sites.
Journal of Clinical
Oncology 2002, Vol. 20:
3156 - 3164Pelvic Tumors
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Cervical Carcinoma
Thermoradiotherapy … was well tolerated
and did not significantly add to either the
relevant clinical acute or long-term toxicity
over radiation alone. A complete response was
achieved in 50% in the radiotherapy group versus
80% in the thermoradiotherapy group. The 3-year
local relapse-free survival of the patients
who were treated with thermoradiotherapy (79.7%)
was significantly better than that of the patients
treated with radiotherapy (48.5%).
International
Journal of Hyperthermia 2001, Vol. 17: 97 -
105Prostate Cancer
Rectal
Carcinoma
Preoperative radiochemotherapy is a widely used
means of treatment for patients suffering from
primary, locally advanced, or recurrent rectal
cancer. We evaluated the efficacy of treatment
due to additional application of regional hyperthermia
…
The rate of resectability (89%) and response
(59%) were high … In this study, …,
there exists a positive interrelationship between
thermal parameters (…) and clinical parameters
concerning effectiveness.
International Journal
Radiation Oncology Biol. Phys. 2000, Vol. 48:
381 - 391 |
∑
Treatment Base Unit
The ∑ treatment base unit
includes the patient and applicator support
system. The patient is placed on the support
sling and prepared for therapy. The applicator
is then placed over the tumor region and the
water bolus is filled from a water reservoir
located in the base. During treatment the bolus
water is circulated to provide comfortable cooling
to the patient.
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Computer
System
The entire *BSD 2000 hyperthermia
system is
controlled by a Pentium® computer running
the Windows© 2000 Professional operating
system. A large flat screen LCD monitor, cordless
keyboard, and cordless mouse create an ergonomic
operator interface to the system.
Hardcopy treatment reports can be produced by
a high resolution color inkjet printer included
with the system.
Click for a larger image
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Quad-Amplifier
The 4-channel solid state
amplifier operates in the frequency range of
75 to 140 MHz and delivers up to 1200 Watt of
microwave power to the applicator. Each channel
is monitored and controlled by computer and
can be individually adjusted for phase and amplitude
according to the optimized requirements of each
treatment session. The amplifier, located remote
from the patient and operators, is contained
within a 24" mounting rack and requires
minimal maintenance.
Thermometry
For temperature measurements
the system is equipped with a ceiling mounted
interface box, which supports up to eight temperature
probes. The Bowman type temperature probes have
a diameter of 1.1 mm and an accuracy of ±
0.1 °C. They are non-perturbing to radio
frequency fields and allow accurate and continuous
monitoring of temperature measurements during
treatment.
A thermal
mapping system is integrated into the hardware
and software system to add a comprehensive set
of mapping, thermal dose calculation, data display,
and printout capabilities. Thermal mapping is
an advanced automated thermometry system that
periodically shifts temperature probes to multiple
locations within the implanted catheter during
treatment. Temperatures are automatically recorded
during this process to provide temperature scans
along the entire catheter length. The probes
are automatically repositioned after the scans.
The temperature scan plots (temperature profiles)
are displayed on the system monitor and can
be printed. |
∑
60 Ellipse (∑ 60-E) applicator
was designed for routine
clinical treatment. It combines the reliable
and sophisticated heating capability of the
∑ 60 with improved patient comfort. The ∑ 60-E
includes an integrated water bolus for coupling
and surface cooling which enables quick and
easy patient setup. The 4 channels of the Quad
Amplifier drive the eight paired antennae of
the applicator. Power and phase of each channel
can be adjusted by computer to create an optimized
two dimensional conformal heating pattern.
∑ 60 - Big Adults
For patients who do not
fit in the ∑ Ellipse applicator because of their
dimensions, the cylindrical ∑ 60 is the applicator
of choice. With an opening diameter of 60 cm
it even allows treatment of patients with severe
adiposis. The integrated water bolus provides
both coupling for the electromagnetic energy
and surface cooling for the patient. With four
power inputs the applicator creates a two dimensionally
focused heating field that conforms to the tumor
region.
∑ 30 - Adult Extremities
- Children
The ∑ 30 was designed for
the treatment of limbs. The ∑ 30 has the same
technical features as the ∑ 60 but the opening
is only 30 cm.
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*∑ 40
- Adolescents - Pediatrics
The ∑ 40 cylindrical applicator
was designed for the treatments of children,
juveniles and small adults. The 40 cm opening
is ideally suited for those patients. The
integrated water bolus provides both coupling
for the electromagnetic energy and surface
cooling for the patient. With four power inputs
the applicator creates a two dimensionally
focused heating field that conforms to the
tumor region.
* Currently For Foreign Distribution Only.
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| The software provides
a user friendly, intuitive color-graphics interface
for the system operator. The software guides the
user through the setup and treatment procedure
and offers icon selectable adjustments of the
treatment parameters. The operator can easily
switch between various screen displays by using
the appropriate tabs. The software provides all
treatment control, treatment data storage and
treatment data recall capabilities. Treatment
data can easily be transferred to a third party
spreadsheet and data processing software, such
as Microsoft® Excel©. |
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| Phase
and amplitude steering of the four generator channels
is used to focus the electromagnetic energy to
the tumor region. Phase and amplitude settings
are controlled by the computer system. The operator
inputs the desired settings for amplitude and
phase, and the system will then adjust and maintain
the correct values. The optional software program,
HyperPlan, was developed to provide individual,
patient and tumor optimized, pretreatment planning.
HyperPlan – developed by the Konrad-Zuse-Institute
and the Charité University Hospital in
Berlin – is dedicated software for 3-dimensional
hyperthermia treatment planning that uses the
CT and/or MRI data of the patient to determine
patient specific optimized treatment settings. |
The patient
data is segmented semi automatically in different
tissue types (e.g. bones, muscle, fat, tumor).
After selecting the appropriate applicator for
the treatment, the electrical field distribution
is calculated by solving Maxwell's equations.
With an optimization module the field maximum
can be conformed to the tumor region. The system
outputs the optimized settings for amplitudes
and phases. A prediction of the temperature distribution
can also be calculated by, using preset perfusion
factors for each tissue type. |
A standard
hyperthermia suite consists of the treatment
room, the operator room and a small technical
room. For convenient patient handling a treatment
room with electromagnetic shielding and a footprint
of 24 to 35 m2 is required. The adjoinig operator
room should have a footprint of 12 to 16 m2
and an observation window into the treatment
room. A small technical room with footprint
of 8 to 10 m2 is required for installation of
the Quad Amplifier. Our site-planning specialists
will assist you in finding the ideal layout
for your given environment. Our installation
drawings include all requirements for building
services, electricity, air conditioning, etc.
Site Planning
We offer complete site planning
assistance to ensure proper installation and
efficient clinical design of the clinical facility.
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*CAUTION:
Investigational device. Limited by Federal (or
United States) law to investigational use. Safety and effectiveness have not been established
for this device. |
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BSD 500
