HIFU - Focused Beam Ultrasonic
- From: J <nexsw@nvalid,anon>
- Date: Thu, 30 Aug 2007 20:25:20 -0400
Tim Jackson wrote:
Smitty88 wrote:
Curious to know if there has been any talk or experience here about HIFU
(high intensity focused ultrasound) (sometimes FUS or HIFUS)focused beam
ultrasonic cancer treatment as an alternative to focused radiation
treatment. As in focused radiation treatment several energy sources
direct sonic energy to a tumor, burning it off.
I spotted info at: http://en.wikipedia.org/wiki/HIFU
Steve J.
Someone asked about it a while ago, and I Googled it. That's all I know.
They are doing it in China, and a company is recruiting patients in the UK.
Obviously, being focussed it is only good for solid tumours in soft
tissue, basically as an alternative to surgery. But unlike surgery
there is no easy way of telling whether everything has been removed, you
can't get 'clean margins'.
So as yet its application in breast cancer is pretty limited, being not
as safe as surgery for a primary tumour, and not suitable for the
commonest mets: in bone, that will throw the focus.
It might be applicable for some of the other mets, eg liver, but the
benefits are limited as removal of the major metastasis often just
encourages the growth of others, so chemotherapy is then a better option
as it attacks the micro-metastases first. Maybe a combination of the
two might sometimes be useful.
Tim
http://www.sciencenews.org/articles/20060429/bob8.asp
Week of April 29, 2006; Vol. 169, No. 17 , p. 264
Ultrasound's New Focus
Can it eradicate tumors?
Ben Harder
The Dominican Republic is known among tourists for its white sands, magnificent
waterfalls, and unusual wildlife. But none of those was the attraction that
drew Charles A. Reinwald. He came for a rendezvous with an ultrasound device.
Reinwald had aggressive prostate cancer, and he didn't care for the treatment
options available in the United States. So, one day in late June 2004, Reinwald
traveled from his home in Tequesta, Fla., to a hospital in the Dominican city
of Santiago. There, a Miami-based urologist directed ultrasonic waves at the
patient's cancerous prostate gland.
a7227_1318.jpg
AIM AND FIRE. Inserted into the rectum, an ultrasound device images the
prostate (top) and then focuses tumor-killing waves at points inside the gland
(bottom).
THS International, Inc.
The Dominican Republic and various other countries, including Canada, England,
and Mexico, permit doctors to treat prostate cancer with a technique called
high-intensity focused ultrasound, or HIFU. It often avoids the irreversible
side effects, including impotence, that can arise during surgery, radiation,
and the other treatments available in the United States.
In the Santiago hospital, urologist George Suarez and his assistants inserted a
transducer emitting ultrasonic waves into Reinwald's rectum. The curved
transducer put the waves on converging paths in the same way that a magnifying
glass focuses sunlight. Where the streams of energy intersected at the
prostate, the temperature soared to more than 80°C, cooking small batches of
tumor cells in seconds.
For about 2 hours, the transducer steadily shifted its aim across rows of
space. Its progress resembled that of a dot matrix printer applying ink to
paper. Tissue just millimeters away from the HIFU target zone remained
unharmed.
Reinwald's cancer isn't cured, but he hasn't required medical intervention
since the operation. At age 80, he works full-time as president of the Cancer
Cure Coalition, a nonprofit organization that he founded in 2000 after his
wife's diagnosis of cancer.
He expresses no regrets about his HIFU treatment. "Why do [surgery] when I have
available to me a less toxic treatment?" he asks.
HIFU, however, is not generally available in the United States. It has been
approved for only one use: treating uterine fibroids. Suarez and other
urologists who treat U.S. men who have prostate cancer do so abroad and charge
about $20,000 per case. Patients also need to pay their own way to Santiago,
Toronto, or another foreign city to undergo the procedure.
A handful of companies market HIFU devices. Although they vary in design and
therapeutic purpose, all the machines rely on the same underlying principle.
They focus ultrasound energy at a point several centimeters away from the
transducer and destroy tissue there.
The companies, including US HIFU of Charlotte, N.C., which Suarez partially
owns, have funded research to test whether the new approach is safer and more
effective for a variety of cancers than standard therapies are. Breast, bone,
brain, and liver tumors are among those cancers being treated experimentally
with HIFU. Investigators also continue to study the efficacy of the technique
in women with fibroids. In each case, physicians must place the transducer
within a few centimeters of the target.
While HIFU appears to sidestep some typical side effects of surgery and
radiation, it's not yet clear whether the novel approach is as successful at
curing cancers as those standard treatments are. So far, no study has directly
compared the ultrasound procedure to an established cancer treatment.
A British government body, the National Institute for Clinical Excellence,
maintains that the evidence "appears adequate to support the use of this
procedure for prostate cancer." But it also states in a document that offers
guidance to the National Health Service, "The effects of HIFU for prostate
cancer on quality of life and long-term survival remain uncertain."
Fixing fibroids
Uterine fibroids are nonmalignant tumors that can impair fertility and
sometimes cause pain, heavy menstrual bleeding, and urinary frequency. The
condition has traditionally been treated by surgical removal of the uterus, or
hysterectomy. This approach definitively rids a woman of fibroids and relieves
the pressure that the fibroids had placed on nearby tissues.
In contrast, HIFU "does not totally get rid of the fibroids," says radiologist
Fiona Fennessy of Brigham and Women's Hospital in Boston. "This isn't a
malignant tumor. All we're trying to do is improve symptoms."
To minimize risks such as skin burns and damage to healthy internal tissues,
radiologists destroy only the center of the fibroid and don't attempt to heat
the surrounding area, called the margin, Fennessy says.
However, because the blood vessels that support a fibroid are concentrated near
its core, destroying the center usually eliminates part of the margin, says
gynecologist Phyllis Gee, director of the North Texas Uterine Fibroid Institute
in Plano.
To evaluate HIFU's success, Brigham and Women's researchers led by gynecologist
Elizabeth A. Stewart treated more than 100 women who had fibroids. The team
used a machine made by InSightec Ltd. of Haifa, Israel, that incorporates an
ultrasound transducer into a magnetic-resonance (MR) scanner.
During treatment, a sedated woman lies facedown on the bed of the scanner.
Beneath her abdomen, the ultrasound transducer aims and fires away for up to 3
hours while the MR scanner lets doctors monitor tissue temperature and fibroid
position.
Most patients experience a "mild level of pain" during and immediately after
procedure, Stewart says.
Stewart's team reported in the January Fertility and Sterility that 71 percent
of the patients treated have a significant reduction in fibroid symptoms for at
least 6 months, and 51 percent experience that improvement for at least a year.
HIFU doesn't produce sufficient relief for all women, however. Seventeen
percent of the volunteers sought another treatment, such as hysterectomy,
within a year, Stewart says.
Women treated with HIFU missed an average of 1.4 days of work after the
operation, Stewart says. That compares with 18.9 missed days among women
treated by hysterectomy for similar fibroids, Stewart reported in Jerusalem
last June to the Israel Society of Obstetrics and Gynecology.
To measure the benefit 3 years after treatment, Gee is leading a new study that
will track 70 women with fibroids who received HIFU. InSightec funded both
studies.
After reviewing preliminary clinical data, the U.S. Food and Drug
Administration in late 2004 approved the InSightec equipment for clinical use
in treating fibroids.
Sounding out malignancies
Unlike fibroids, malignant tumors need to be rooted out entirely if they're to
be beaten. In surgery, doctors remove a specific amount of surrounding healthy
tissue to avoid leaving behind any cancer cells. Similarly, in HIFU, doctors
may need to kill a veneer of healthy tissue around each tumor, concluded Moshe
Papa and Douglas Zippel of Sheba Medical Center in Tel Hashomer, Israel, in the
January 2005 Breast Cancer.
Those researchers used HIFU to treat 10 women who had breast cancer and were
planning to have partial mastectomies. After the procedure, the investigators
removed a portion of each treated breast to see whether HIFU had eliminated the
tumors. Two volunteers showed no sign of remaining cancer, but eight patients
retained at least some cancerous cells at the tumor site.
Feng Wu and his colleagues in Chongqing, China, have taken a more aggressive
approach. Between 1998 and 2001, they administered HIFU?in combination with
either surgery or chemotherapy?to 45 women with breast cancer. They
intentionally destroyed a 1.5-to-2-centimeter-thick layer of normal tissue
around each tumor.
Five years later, 89 percent of the women had had no recurrence of disease, Wu
reported last December at the Radiological Society of North America meeting in
Chicago.
Wu holds stock in the company that makes the device that his team tested.
The study didn't include a comparison group of similar patients receiving a
conventional treatment.
In other studies, it's not uncommon to find that after surgery and radiation
therapy, more than 90 percent of volunteers who have breast cancer go at least
5 years without recurrence.
InSightec-sponsored researchers have begun a trial of HIFU in treating breast
tumors and surrounding breast tissue in 200 women in Germany and Japan.
The cosmetic side effects of HIFU are minimal. Since HIFU doesn't break the
skin, it rarely disfigures the breast, Wu says.
David Gianfelice of Toronto General Hospital, one of the first North American
researchers to use HIFU in breast cancer treatment, notes that third-degree
skin burns have resulted in some cases. But recent refinements to the InSightec
hardware have minimized that problem, he says.
By delivering "a nice, tight package of heat" to the tumor, MR-guided HIFU
might eventually supplant surgery as the treatment in some cases of breast
cancer, Gianfelice says.
That same goal applies in prostate cancer, which researchers abroad have been
treating with HIFU since the mid-1990s. For example, more than 400 men with
early-to-mid-stage prostate cancer have received HIFU as an initial therapy
using the device manufactured by EDAP of Vaulx-en-Velin, France.
Andreas Blana and his colleagues at the University of Regensburg in Germany
reported results from 146 of these patients, who were tracked for an average of
nearly 2 years. Blana's team reported in the February 2004 Urology that 87
percent of the patients remained free of their cancer. In studies of
traditional prostate cancer therapies, up to 95 percent of men with early-stage
cancer remain cancerfree at least 5 years after treatment.
At Hachioji Hospital in Tokyo, Toyoaki Uchida and his colleagues have treated
more than 200 men since 1999.
Overall, 81 percent of the men remained free of disease 1 year after the
procedure, and 77 percent had no disease after 5 years, Uchida reported at a
meeting of the International Society for Therapeutic Ultrasound in Boston last
October.
But more evidence is needed to prove that HIFU rids men of cancer as
effectively as established therapies do, says urologist Peter Scardino of
Memorial Sloan-Kettering Cancer Center in New York City.
Other researchers are now testing HIFU in patients with terminal liver or brain
cancer or patients in whom tumors from other organs have spread to bone. These
trials are intended to relieve pain.
Just warming up
In addition to scoring direct hits against cancer, HIFU may provide assists
when used in combination with established drugs. Researchers at the National
Institutes of Health's Clinical Center in Bethesda, Md., showed at last year's
radiology meeting that HIFU can boost the amount of a chemotherapy drug that
reaches a tumor. Sergio Dromi and his colleagues injected skin tumor?carrying
mice with microscopic envelopes of fat, called liposomes, that contained the
anticancer drug doxorubicin. Liposomes carry drugs and other substances into
cells.
In some mice, the researchers then used a HIFU machine to deliver intermittent
pulses of ultrasound energy to each tumor, elevating its temperature to 42°C
and breaking down the liposomes. Examination of the tumors revealed that three
times as much doxorubicin reached the target in the HIFU-treated mice as in the
other mice.
Other researchers are pursuing HIFU as a method for cauterizing hemorrhaging
internal wounds (SN: 1/6/01, p. 12: Available to subscribers at
http://www.sciencenews.org/articles/20010106/bob8.asp) and breaking up blood
clots and kidney stones (SN: 11/26/05, p. 346: Available to subscribers at
http://www.sciencenews.org/articles/20051126/bob10.asp).
Suarez, the urologist who treated Reinwald in Santiago, anticipates that HIFU
may treat pancreatic and kidney cancer, fix heart arrhythmias, and even improve
liposuction.
Use of HIFU for cancer could dramatically reduce health care costs, argues
Suarez. It requires little or no hospitalization and less recovery time than
alternative treatments do. Because HIFU is associated with a low rate of
permanent complications, it also decreases the cost of treating those side
effects.
"I'm treating about 20 patients a month [with HIFU]," Suarez says. "We are
concentrating on prostate cancer right now. There's a sense of urgency?it is
the most common cancer in men."
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References:
Blana, A., et al. 2004. High-intensity focused ultrasound for the treatment of
localized prostate cancer: 5-year experience. Urology 63(February):297-300.
Abstract available at http://dx.doi.org/10.1016/j.urology.2003.09.020.
Dromi, S., et al. 2005. Pulsed-high intensity focused ultrasound (HIFU)
enhanced delivery of doxorubicin using heat sensitive liposome (Thermodox).
Meeting of the Radiological Society of North America. Dec. 1. Chicago.
Abstract.
Fennessy, F., . . . E.A. Stewart, et al. 2005. Evaluation of symptom relief and
fibroid reduction one year following MR-guided focused ultrasound surgery.
Meeting of the Radiological Society of North America. Nov. 28. Chicago.
Abstract.
National Institute for Clinical Excellence. 2005. High-intensity focused
ultrasound for prostate cancer. Interventional Procedure Guidance 118 (March).
Stewart, E.A., et al. 2006. Clinical outcomes of focused ultrasound surgery for
the treatment of uterine fibroids. Fertility and Sterility 85(January):22-29.
Abstract available at http://dx.doi.org/10.1016/j.fertnstert.2005.04.072.
Stewart, E.A. 2005. MR guided focused ultrasound: A fibroid-specific treatment.
Meeting of the Israel Society of Obstetrics and Gynecology, June 5: Jerusalem.
Available at http://www.obgyn.net/hysterectomy-alternatives/
mrgfus/presentation/player.html.
Uchida, T., et al. 2006. Treatment of localized prostate cancer using
high-intesity focused ultrasound. BJU International 97(January):56-61. Abstract
available at http://dx.doi.org/10.1111/j.1464-410X.2006.05864.x.
Uchida, T., et al. 2005. Transrectal high-intensity focused ultrasound in the
treatment of localized prostate cancer: A multicenter study. Hinyokika Kiyo
51(October):651-658. Abstract.
Uchida, T. 2005. HIFU for localized prostate cancer: 6 year experience. Meeting
of the International Society for Therapeutic Ultrasound. Oct. 27-29. Boston.
Wu, F., et al. 2005. Clinical phase II and phase III trials using high
intensity focused ultrasound treatment for patients with breast cancer. Meeting
of the Radiological Society of North America. Dec. 2. Chicago. Abstract.
______. 2003. A randomized clinical trial of high-intensity focused ultrasound
ablation for the treatment of patients with localized breast cancer. British
Journal of Cancer 89(Dec. 15):2227-2233. Abstract available at
http://dx.doi.org/10.1038/sj.bjc.6601411.
Zippel, D.B., and M.Z. Papa. 2005. The use of MR imaging guided focused
ultrasound in breast cancer patients; a preliminary phase one study and review.
Breast Cancer 12(January):32-38. Available at
http://www.jstage.jst.go.jp/article/jbcs/12/1/12_32/_article.
See web page for "Sources" and "Further readings"
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<
http://www.nature.com/bjc/journal/v89/n12/abs/6601411a.html;jsessionid=84749763531FA5510F2455132A1B3992
British Journal of Cancer (2003) 89, 2227-2233.
doi:10.1038/sj.bjc.6601411
A randomised clinical trial of high-intensity focused ultrasound ablation for
the treatment of patients with localised breast cancer
F Wu1, Z-B Wang1, Y-De Cao1, W-Z Chen1, J Bai1, J-Z Zou1 and H Zhu1
1Institute of Ultrasonic Engineering in Medicine, and Clinical Center for Tumor
Therapy of 2nd Hospital, Chongqing University of Medical Sciences, Box 153, 1
Medical College Road, Chongqing 400016, China
Correspondence to: Dr F Wu, [...]
Received 24 April 2003; revised 26 August 2003; accepted 12 September 2003
High-intensity focused ultrasound (HIFU) is a noninvasive treatment that
induces complete coagulative necrosis of a tumour at depth through the intact
skin.
This study was to explore the possibility of using HIFU for the treatment of
patients with localised breast cancer in a controlled clinical trial.
A total of 48 women with biopsy-proven breast cancer (T1-2, N0-2, M0) were
randomised to the control group in which modified radical mastectomy was
performed, and the HIFU group in which an extracorporeal HIFU ablation of
breast cancer was followed by modified radical mastectomy.
Short-term follow-up, pathologic and immunohistochemical stains were performed
to assess the therapeutic effects on tumour and complications of HIFU.
The results showed that no severe side effect was observed in the HIFU-treated
patients.
Pathologic findings revealed that HIFU-treated tumour cells underwent complete
coagulative necrosis, and tumour vascular vessels were severely damaged.
Immunohistochemical staining showed that no expression of PCNA, MMP-9, and
CD44v6 was detected within the treated tumour cells in the HIFU group,
indicating that the treated tumour cells lost the abilities of proliferation,
invasion, and metastasis. I
t is concluded that, as a noninvasive therapy, HIFU could be effective, safe,
and feasible in the extracorporeal treatment of localised breast cancer.
Keywords: high-intensity focused ultrasound; focused ultrasound surgery; breast
carcinomas; therapy; ablation
http://clinicaltrials.gov/ct/show/NCT00008437
MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or
Stage IIIA Breast Cancer
This study is no longer recruiting patients.
Sponsored by: InSightec, Limited
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00008437
Purpose
RATIONALE: Imaging procedures, such as MRI, may allow the doctor to better
detect the tumor. Highly focused ultrasound energy may be able to kill tumor
cells by heating the breast tumor cells without affecting the surrounding
tissue.
PURPOSE: Phase II trial to study the effectiveness of MRI-guided ultrasound
energy in treating women who have stage I, stage II, or stage IIIA breast
cancer.
Condition Intervention Phase
Breast Cancer
Procedure: ablation therapy
Procedure: high-intensity focused ultrasound ablation
Procedure: hyperthermia
Record first received: January 6, 2001
OUTLINE: This is a pilot study.
Patients undergo MRI-guided focused ultrasound (MRgFUS) ablation of the breast
lesion using a series of pulses. Within 72 hours after MRgFUS procedure,
patients undergo gadolinium-enhanced MRI to evaluate ablation borders. Within
7-10 days after MRgFUS procedure, patients undergo an ultrasound exam. Guide
wires may be placed to assist in pre-surgical lesion localization. Within 10-21
days after MRgFUS procedure, patients undergo segmental resection or
mastectomy.
.
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