Hifu And Clinical Trials
HIFU is not available in every hospital. Your doctor might offer you HIFU treatment as part of a clinical trial. Or you might need to travel to specialist centre for treatment.
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Focal therapy using high-intensity focused ultrasound for localised prostate cancerNational Institute for Health and Care Excellence , 2012
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A multicentre study of 5 year outcomes following focal therapy in treating clinically significant non metastatic prostate cancerS Guillaumier and others
How Is Hifu Treatment Given
You have HIFU under a general anaesthetic or a spinal anaesthetic. You can usually go home when you have recovered from the anaesthetic.
The surgeon passes a probe into the back passage . It produces beams of high-energy ultrasound that heats and destroys the area of prostate cancer cells. The probe is surrounded by a cooling balloon so the high-energy beams are only given to the areas with cancer. This means the normal prostate tissue is protected.
Is Hifu Approved By The Fda
HIFU was approved by the Food and Drug Administration in 2015 to remove prostate tissue. It has not been approved to treat prostate cancer and is considered investigational in the United States. If you have been diagnosed with prostate cancer, HIFU may be a treatment option for you through a clinical trial. Your doctor can help you understand your eligibility and address any questions you may have.
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How Does High Intensity Focused Ultrasound Work
HIFU destroys prostate cancer through the delivery of precise and focused sound waves to a targeted spot of diseased prostate tissue. This technology uses ultrasound energy, not radiation, to destroy the targeted tissue. The Ultrasound energy, or sound waves, is transmitted through the rectal wall and focused at desired locations within the prostate identified by MRI and confirmed by ultrasound. This targeted and minimally invasive approach to treating prostate cancer leaves the healthy tissue untouched and unharmed and minimizes the chance of side effects.
The basic concept of how HIFU targets, burns and destroys specific prostate tissue is similar to how a magnifying glass can use the suns rays of light to burn a precise hole in a leaf at the point of intersection. Similar principles apply to HIFU. Instead of using light as the source of energy, HIFU uses sound, and instead of a magnifying glass, HIFU uses a transducer. The sound waves that are aimed at the prostate tissue, rapidly increase tissue temperature, destroying only the cancerous lesions and protecting the healthy surrounding tissue.
Hifu Experimental Identification And Essential Clinical Parameters
Computer simulation, in vitro and in vivo studies were conducted to identify and refine the ultrasound parameters required for the clinical treatment of prostatic disease. The destruction of PC with HIFU in these studies provided the evidence that prostate cancerous tissues can be destroyed by HIFU without inducing metastases, and that prostatic tissue can effectively be targeted through transrectal delivery of HIFU .
Essential clinical parameters for the medical use of HIFU include ultrasound frequency , acoustic intensity , duration of application , intervals of the pulses , lateral distance between elementary lesions, longitudinal displacement of the energy source when applying multiple lesions, and penetration depth dependent on the applicator design .
These multiple technical parameters are essential in the assembly of a HIFU system with a dedicated application for specific tissue. Complex technical decisions are involved in HIFU operation, and include the selection and design of the piezoelectric energy applicator, parameters of ultrasound treatment , application algorithm , imaging system, intraoperative target and safety features, target localization during treatment with transrectal ultrasound and controls .
Current standard urological applications use HIFU transducers with a fixed but adjustable focal point to be moved mechanically to treat a larger tissue volume .
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Can Prostate Cancer Be Managed
Typically, there are 3 ways to manage prostate cancer. Because prostate cancer is slow-growing, it may not have a significant impact the wellbeing of most men for the remainder of their lifetime. For these conditions, active surveillance may be recommended, giving the patient and the doctor more time to assess the progression of the disease and consider options for treatment.
When more significant treatment is recommended, it may include surgery or radiotherapy, or both. These treatments tend to be a final procedure, where the treatment plan is designed to eliminate the progression and spread of cancer cells without the need for additional treatment. Recent innovations, such as with robotic surgery for prostate, reduces recovery time while retaining function, but can still produce some side-effects. Other advancements exist in radiotherapy devices, which has vastly improved treatment delivery methods and clinical outcomes.
HIFU treatment provides an additional treatment option that is designed to bridge the gap between active surveillance and the more significant treatments, such as radical prostatectomy . HIFU Focal One® treatment consists an ultrasonic probe that scans the entire prostate structure then focuses sound waves at only the cancerous portion of the prostate from within the rectum.
Hifu Efficacy In The Treatment Of Prostate Cancer
Thousands of patient stories prove that prostate cancer is curable. Radiation therapy, radiosurgery and prostatectomy are the standards of treatment with survival rates exceeding 90%. However, after them, patients have a high risk of developing side effects in the intestines and genitourinary system. Treatment with high-intensity focused ultrasound can cure prostate cancer with less pronounced side effects.
HIFU for prostate cancer shows good long-term results. According to observations of French and German medical centres, the 10-year survival rate of patients after HIFU ranges from 92% to 99%.
The ultrasonic ablation procedure has side effects. The most common manifestations include incontinence, difficulties in urination, decreased erectile function. Studies by the French Association of Urologists have shown that these side effects gradually disappear in 97% of patients.
The FDA has approved HIFU for prostate cancer treatment.
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Hifu For Prostate Cancer
For over 2 decades, HIFU has been used to treat over 40,000 prostate cancer patients worldwide, with the number increasing daily. High Intensity Focused Ultrasound is a non-invasive prostate cancer treatment requiring no radiation or surgery. It is performed on an outpatient basis, with excellent cure outcomes and minimal side effects.
Surgery and radiotherapy have a high level of morbidity – impotence and incontinence in particular. HIFU offers less downtime and fewer side effects.
The Cleveland Clinic Canada uses the Ablatherm HIFU device to treat prostate cancer. The device, developed since 1993, is continually upgraded and evolving. This French technology targets prostate tissue with pinpoint accuracy, preserving the surrounding tissue. Ablatherm HIFU has received regulatory clearance in over 30 countries including Canada, the United States, Europe, Australia and elsewhere.
Best HIFU Clinic
The Cleveland Clinic Canada is the most experienced HIFU treatment center in North America. We have treated patients for over a decade under the approval of Health Canada.
We believe that experience matters – which is why men travel to Toronto from all over North America for the procedure.
At our HIFU clinic, you will receive personal care and assistance with travel plans. From your first contact with our Registered Nurses, to the urologists personal cell phone number, you will understand why we are the leading HIFU clinic in North America.
When Is Hifu Treatment Used
HIFU can be used to treat the whole prostate gland when the cancer is in more than one area. It is also used when there is only one small area of cancer in the prostate gland .
If there are areas of cancer that are growing quickly you can have focal treatment to these. Very slow-growing areas of cancer may not be treated. You may have fewer side effects because less healthy tissue is damaged.
If the cancer comes back after HIFU treatment, you may still be able to have treatment with surgery or radiotherapy. You will have your PSA level checked regularly after treatment.
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Possible Benefits And Disadvantages Of Hifu
If you are thinking about having HIFU, your doctor can explain the benefits and disadvantages. They will also tell you about the other treatment options available to you.
Doctors still do not know enough about how effective HIFU treatment is compared to existing treatments for early prostate cancer. Active surveillance, which involves monitoring the cancer, may be an option.
Side effects, such as erection difficulties and urinary problems may be less of a problem with these treatments. But they may still affect you. If you have already hadtreatment for prostate cancer, the side effects may be worse.
Some people may prefer to have HIFU even though there is not enough evidence about them yet. They may feel there is less risk of certain side effects and want to avoid surgery or radiotherapy. Or, it may be because these treatments can be given in a short hospital stay and recovery is usually quick.
In Which Clinics Is Hifu Therapy Available
HIFU-therapy for cancer treatment is not available in all clinics. This is because the procedure is still under clinical trials in the USA and is not popular among patients. High-quality diagnostics to identify indications and contraindications to HIFU and conduct the procedure itself according to European standards requires high qualification of doctors. For this reason, the method is available in clinics where oncology treatment is highly developed:
Souraski Medical Center .
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What Can I Expect During And After The Procedure
HIFU is an outpatient procedure performed under light sedation. The treatment takes one to two hours and you will be able to return home the same day.
Catheter
You may require a catheter for a few days following the procedure. Your treating doctor will discuss this with you.
Medication
Cialis/Levitra/Viagra-type medications should be taken as directed. These medications assist with the healing process even if you anticipate no sexual activity.
Testing
PSA tests are used to track your outcome from the HIFU procedure. We recommend tests at 3, 6, 9, and 12 months post-treatment. During the second year the PSA should be monitored at 6-month intervals. Once your PSA level is stable, your doctor will determine the appropriate interval for monitoring.
High Intensity Focused Ultrasound
Now patients have another option for treating prostate cancer besides radiation or surgery. HIFU is minimally invasive, and patients can go home the same day. The treatment is highly focused, sparing surrounding tissue and reducing the risk side of effects such as incontinence and erectile dysfunction.
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Questions To Ask Your Doctor Or Nurse
- What are the advantages and disadvantages of HIFU?
- Where is this treatment available?
- Can I see the results of HIFU treatments you have carried out?
- What are my other treatment options?
- Will I have focal HIFU or whole-prostate HIFU?
- What are the side effects of HIFU? How likely am I to get them?
- How can I manage any side effects I get?
- How will I know if the treatment has worked?
- How likely is it that Ill need more treatment after HIFU?
- What treatments are available after HIFU?
How Can I Undergo Treatment Abroad
The medical tourism operator Booking Health will help organize diagnostics and treatment abroad. We will select a foreign hospital that demonstrates the best results in the treatment of prostate cancer.
Booking Health offers the following services:
- Communication with the selected clinic
- Translation of medical documents
- Registration of visa and health insurance
- Provision of the most favorable prices for the medical program by avoiding additional coefficients for foreign patients
- Accompaniment by an interpreter
- Booking airline tickets and hotel, transfer from the airport and back
Booking Health ensures treatment in the best hospitals for patients from all over the world. You just need to leave a request on the website, and our employee will contact you as soon as possible to clarify the peculiarities of the trip.
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What Does Hifu Involve
Each hospital will do things slightly differently. Weve included some general information about what might happen before, during and after HIFU. Your doctor or nurse will give you more information about your treatment.
Before your treatment
If you have a large prostate, you might be offered other treatments before you have HIFU.
- Hormone therapy is sometimes given for two to three months before HIFU. This can make the prostate smaller, and make the cancer easier to treat.
- Transurethral resection of the prostate is an operation to remove prostate tissue and improve the flow of urine. This operation is sometimes used before HIFU to reduce the risk of some urinary problems after the treatment.
As with all treatments, these can cause side effects.
If youre having focal HIFU, you will usually go to a screening appointment first. Youll have a magnetic resonance imaging scan, which produces detailed images of the prostate and shows the location of the cancer. You may also have a prostate biopsy, which shows the location of the cancer and how likely the cancer is to grow and spread outside the prostate. These tests will help your surgeon target the area of the prostate that needs to be treated.
During your treatment
You will usually have a general anaesthetic so that youre asleep during the treatment.
Your surgeon will plan your treatment so the HIFU machine moves the beam around, heating and destroying the cancer cells in the area being treated.
Focal HIFU
Whole prostate HIFU
Predictions Of Pancreatic Cancer Treatment With Hifu
More than 80% of patients with pancreatic cancer have advanced disease and are not suitable for surgery. Standard treatment options for non-surgical pancreatic cancer include chemotherapy, radiation therapy, or a combination thereof.
The inclusion of HIFU therapy in this list can extend the life of the patient. At the same time, 81% of cancer patients have severe abdominal pain. The researchers called HIFU a safe and effective treatment for pancreatic cancer.
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How Does Hifu Work
If you’ve ever used a magnifying glass to reflect the sun’s rays and start a tiny fire or burn a hole into a leaf, you already have an idea of how HIFU works. Instead of light rays, though, HIFU uses sound waves that a doctor points through the wall of your rectum — the bottom part of your large intestine. They’ll direct the waves at your cancer cells.
The sound waves heat up to temperatures as high as 90 C and can kill cancer cells in just a few seconds. Doctors use magnetic resonance imaging and ultrasound imaging to find out exactly where the tumor is and where to point the sound waves.
What Happens During The High
During high-intensity focused ultrasound , an ultrasound probe about the size of your index finger is inserted into your rectum while you are asleep under anesthesia. The probe is positioned up to the level of your prostate. Your prostate is located immediately behind the rectum wall.
An imaging transducer in the center of the probe scans your prostate to create a three dimensional computerized map of your entire prostate and the area to be treated. Your urologist then uses the computer to view and plan your precise treatment plan. The treatment plan is then carried out, with focused waves of ultrasound destroying the exact identified tissue. Each focused beam of energy destroys about a rice-grain size of tissue at a time. The session continues until all the diseased tissue is destroyed. After the treatment session, imaging reviews the result of the treatment.
The procedure takes an average of two hours to perform depending on the size of the treatment area.
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Future Perspectives Of Hifu For Cancer Treatment
HIFU is a non-invasive method of destroying a target tissue without skin incision whilst sparing adjacent tissues and organs, using real-time imaging guidance and control. The HIFU treatment involves relatively little pain and can be carried out with conscious sedation and on an outpatient basis. Such a technology provides a personalized treatment, adjusted to the individual patient anatomy, pathology and treatment response. The combination of Magnetic Resonance Imaging and Focused Ultrasound , known as MRgFUS, provides an ability to plan and monitor treatment in near real time, with MRgFUS further increasing the safety profile of FUS due to real-time temperature mapping . Combined strategies have been recently addressed, in order to match the advantages of both imaging modalities . Moreover, MRgFUS allows for achieving a higher degree of accuracy in ablation of the affected tissue . In particular, MRI has the unique ability to monitor temperature and cavitation level in real time .
Opposite to thermal induction, the mechanical impact from HIFU might be considered as an alternative for eliciting apoptosis. In a recent study, researchers exploited MR-guided HIFU for inducing apoptosis, where moderate acoustic power was applied .
Does Hifu Help Cure Primary And Secondary Liver Cancer
HIFU-therapy is recognized as an effective method for treating inoperable liver cancer. 44% of patients live for 5 years, if the cancer process was diagnosed at the 1st or 2nd stage, provided that the liver cancer was treated with chemotherapy or radiotherapy. The researchers at the Journal of Cancer found that 79% of patients successfully undergo HIFU sessions, after which the tumour begins to shrink. In 30% of cancer patients, the tumour is destroyed.
The disadvantage of HIFU is that 8% may have complications. These include obstruction of the biliary tract, pleural effusion, fistula formation, as well as burns, pain and fever.
Treatment with HIFU-therapy for liver cancer is possible in European clinics.
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Are You A Candidate For Hifu
HIFU is best for people with intermediate-risk prostate cancer that hasnt spread and is limited to one area of the prostate. Your urologist will help you understand your specific risks and treatment goals to help you make the best decision for you.
We dont recommend HIFU for cancer that:
- Has spread beyond the prostate gland or into lymph nodes
- Is large or involves both sides of the prostate
In these situations, whole-gland therapies, such as prostatectomy or radiation, may be best.