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Results for “Ultrasound, High-Intensity Focused, Transrectal”

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PubMed2002

[High intensity focused ultrasound alone for malignant solid tumors].

OBJECTIVE: To investigate the efficacy and side-effects of high intensity focused ultrasound (HIFU) in the treatment of malignant solid tumors. METHODS: Thirty such patients who refused surgery and or refractory to chemotherapy, were treated by HIFU alone, with the efficacy and side effects monitored in terms of vital organ signs observation, functional assay of important organs, imaging examinations: digital subtraction angiography (DSA), CT, MRI, single photoemission computed tomography (SPECT), large core needle biopsy, complications or metastasis. RESULTS: After HIFU therapy, the vital signs remained stable and the function of heart, lung, kidney and liver was also normal. DSA images showed that small or larger arteries were not damaged. After a follow-up of 10 - 38 months (23.1 months), 26 patients (87%) have been alive. The volume of the tumor underwent complete regression in 10 patients. Shrinkage of tumor volume >/= 50% was observed in 13. Eight of 13 patients were examined by large core needle biopsy, all showing necrosis and/or fibrosis though 3 patients (10%) had local recurrence. Two of these were retreated again by HIFU and the locally recurrent tumor became well controlled. New metastases developed in 5 patients after HIFU therapy. Two patients suffered from peripheral nerve injuries, most of which have recovered during the follow-up. However, one patient developed skin injury. CONCLUSION: High intensity focused ultrasound alone is effective and safe in the treatment of malignant solid tumors.

Adolescent↗

PubMed2002

[High intensity focused ultrasound in the treatment of primary malignant bone tumor].

OBJECTIVE: To develop a new noninvasive limb-salvaging method in the treatment of primary malignant bone tumor in the extremities. METHODS: Forty-four patients with primary malignant bone tumor were treated by extracorporal high intensity focused ultrasound (HIFU) with or without chemotherapy, with a mean follow-up of 17.6 months. RESULTS: The overall survival and complication rates were 84.1% and 18.2%. In 34 patients with stage II b disease, 30 were disease-free, with 2 died of tumor metastasis to brain and lung and 3 developed local recurrence. In 10 patients with stage III b disease, 5 survived with tumor, with 1 developed local recurrence and 5 died of lung metastasis. Thirty-six of 44 patients were > or = 15 points by Enneking system. CONCLUSION: High intensity focused ultrasound combined with chemotherapy for primary malignant bone tumor in the extremity is proved to be effective and safe, preserving good function in the limbs. HIFU may possibly become a new limb-salvaging treatment for this tumor.

Adolescent↗

PubMed2003

[High intensity focused ultrasound for liver cancer].

OBJECTIVE: To evaluate the effect of high intensity focused ultrasound (HIFU) for liver cancer. METHODS: HIFU treatment was performed in 44 liver cancer patients under general anesthesia and ultrasound positioning. Before and after HIFU treatment, the clinical symptoms, liver functional tests, AFP and MRI were evaluated. RESULTS: After HIFU treatment, the remission rate of clinical symptoms was 87.5% (28/32), with the scanty ascites in 3 patients disappeared. ALT (79.73 +/- 12.31 U/L) and AST (103.47 +/- 24.55 U/L) before HIFU were reduced to normal in 84.6% (22/26) and 73.5% (25/34) patients. AFP in 64.3% (18/28) patients decreased > or = 50% of the original value. After HIFU, MRI showed coagulative necrosis and blood supply reduction or disappearance of tumor in the target region. CONCLUSION: HIFU treatment pocesses good effect on liver cancer, which will offer a considerable weight in noninvasive local treatment of hepatic tumor.

Adult↗

PubMed2003

[Results of transrectal focused ultrasound for the treatment of localized prostate cancer (120 patients with PSA < or + 10ng/ml].

OBJECTIVES: To evaluate the efficacy of high intensity focused ultrasound (HIFU) for the treatment of localized prostate cancer in a population of potentially curable patients. MATERIALS AND METHODS: 120 patients with clinical stage T1-T2 prostate cancer with an initial PSA < or = 10 ng/ml and not candidates for radical prostatectomy were treated by HIFU (ABLATHERM, EDAP S.A.). Clinical failure was defined by the need for adjuvant therapy (endocrine or external beam radiotherapy). Progressive disease (laboratory failure) was strictly defined by identification of residual cancer on follow-up biopsies (regardless of the PSA) or by 3 successive elevations of PSA (when follow-up biopsies were negative) with a velocity greater than 0.75 ng/ml/year. Progression-free survival rates were calculated according to the Kaplan-Meier method. Success rates stratified according to risk factors were compared by Log-rank tests. RESULTS: The patients presented the following characteristics on inclusion: mean age: 71.2 +/- 5.34 years, PSA: 5.67 +/- 2.47 ng/ml, prostatic volume: 33.6 +/- 16.5 cc, stage: T1:61, T2:59, Gleason score 2-6: 77, 7-10: 43. The mean number of HIFU session per patient was 1.5 +/- 0.7. The mean duration of catheterization was 9 days and the mean follow-up was 27 months (range: 3-96 months). Follow-up biopsies did not reveal any residual cancer in 103 patients (86%). A residual cancer was identified in 17 patients, but only 6 patients required adjuvant therapy (endocrine: n = 2, radiotherapy: n = 4), corresponding to a clinical success rate of 95%. Progression-free survival for the whole patient population was 76.9%. A significant difference (p < 0.05) was observed between patients with a Gleason score between 2 and 6 (85.4%) and patients with a Gleason score between 7 and 10 (61.3%). CONCLUSION: These results show that high intensity focused ultrasound is a treatment option achieving similar results to those of other non-surgical treatments for prostate cancer.

Aged↗

PubMed1997

Prostatic tissue ablation by transrectal high intensity focused ultrasound: histological impact and clinical application.

In a phase-I clinical trial the morphologic impact and safety of high-intensity focused ultrasound (HIFU) administered transrectally for tissue ablation in human prostates (n = 54) was evaluated. Location and size of the tissue lesions correlated well with the predefined target area and revealed sharply delineated coagulative necrosis in all cases. Intervening tissues, such as the rectal wall and posterior prostate capsule were invariably intact. In a subsequent phase-II clinical trial safety and efficacy of transrectal HIFU as a novel minimally invasive treatment modality for patients with symptomatic benign prostatic hyperplasia (BPH; n = 102) was determined. The maximum urinary flow rate (Qmax, ml/s) increased from 9.1+/-4.0 to 12.9+/-6.1 (3 months, n=86), 12.7+/-5.1 (6 months, n=78) and 13.3+/-6.1 (12 months, n=56). In the same time period the post void residual volume (ml) decreased from 131+/-115 to 46+/-45, 57+/-46 and 48+/-36 and the AUA symptom score decreased from 24.5+/-4.7 to 13.3+/-4.4, 13.4+/-4.7 and 10.8+/-2.5. A subset of patients (n=30) underwent multichannel pressure flow studies, which demonstrated that transrectal HIFU reduces bladder outflow obstruction. These data demonstrate that transrectal HIFU is capable of inducing coagulative necrosis in the human prostate via a transrectal approach while preserving intervening and adjacent tissue. A 48% improvement of uroflow and a 53% decrease of urinary symptoms 1 year after treatment prove that transrectal HIFU is an effective and safe minimally invasive treatment option for BPH.

Adult↗

PubMed1995

[Minimally invasive therapy of benign prostatic hyperplasia with focussed ultrasound].

To determine the morphologic impact and safety of high-intensity focused ultrasound (HIFU) administered transrectally for tissue ablation, a total of 22 prostates were treated in vivo with transrectal HIFU prior to surgical removal. Location and size of the tissue lesions correlated well with the predefined target area and revealed sharply delineated coagulative necrosis in all cases. In a subsequent phase II clinical trial the clinical effectiveness of transrectal HIFU as a minimally invasive treatment modality for patients with symptomatic benign prostatic hyperplasia (BPH; n = 50) was studied. The maximum urinary flow rate (Qmax, ml/s) increased from 8.9 +/- 0.6 (n = 50; mean +/- SEM) to 12.8 +/- 0.9 (3 months, n = 46), 11.9 +/- 0.9 (6 months, n = 44) and 12.2 +/- 1.0 (12 months, n = 32). Within the same time period, the post-voiding residual volume (ml) decreased from 113 +/- 17 (mean +/- SEM) to 47 +/- 6, 57 +/- 7, and 49 +/- 6. These data demonstrate that transrectal HIFU can induce intraprostatic coagulative necrosis. The phase-II clinical data presented in this paper reveal that transrectal HIFU is an effective and safe minimally invasive treatment option for BPH. Nevertheless, a randomised phase-III trial comparing HIFU and TURP is mandatory to define the definitive role of transrectal HIFU in BPH, and is presently planned.

Adult↗

PubMed2003

Visualisation of HIFU lesions using elastography of the human prostate in vivo: preliminary results.

An imaging system was developed for prostate elastography in vivo using a transrectal ultrasound (US) probe to guide high-intensity focused US (HIFU) therapy of prostate cancer. Uniform compression was applied using a balloon, while a sector image was acquired. Strain was calculated from the gradient of the displacements obtained from the ultrasonic signal using the cross-correlation technique. Elastograms were acquired on a total of 31 patients undergoing HIFU therapy for localised prostate cancer. For two patients, only part of the prostate was treated and posttherapy magnetic resonance imaging (MRI) confirmed the size and position of the HIFU lesions seen in the elastograms as low strain areas, with a strain contrast ratio between 1.6 and 3.2. The whole prostate was treated for the next 29 patients. After treatment, the whole prostate appeared to be stiff in the elastograms and a 40% to 60% (mean 50%) decrease in average strain was observed when compared to strains measured before HIFU application. Tumours identified by biopsies and sonograms could occasionally be seen in the preoperative elastograms. Decorrelation effects occurred mainly because of low sonographic signal-to-noise ratio (SNR) and of out-of-plane motion induced by respiration.

Adenocarcinoma↗

PubMed1993

Prostatic tissue destruction by high-intensity focused ultrasound: experimentation on canine prostate.

High-intensity focused ultrasound (HIFU) has been used transrectally to induce intraprostatic coagulation necrosis lesion in the canine prostate. The device combines a firing system (power amplifier and therapy transducer) and a localization system (ultrasound scanner). Thirty-seven dogs have been treated with ultrasound intensity ranging from 720 W/cm2 to 2300 W/cm2 and shot durations ranging from 1 to 4 seconds. The threshold for focal ultrasonic lesions was determined to be 1000 W/cm2 with a 1-second shot duration. Intraprostatic lesions were obtained without any damage to the rectal wall. These lesions were homogeneous coagulation necroses and progressed first to an inflammatory fibrosis and then to sclerosis with cavity formation. Intraprostatic lesions also occurred with a combination of moderate acoustic intensity (720 W/cm2) and longer shot duration (4 seconds). The temperature reached at the focal point of the transducer was 85 degrees C. The study confirms the possibility of creating irreversible lesions in the prostatic tissue through the rectal wall. The destruction of localized prostatic cancer seems to be possible in the near future using HIFU delivered by the transrectal route.

Animals↗

PubMed1993

High-intensity focused ultrasound in the treatment of prostatic disease.

Beginning in 1987, high-intensity focused ultrasound was investigated experimentally in a canine model to determine whether or not prostate tissue could be destroyed with good aiming and control. Subsequently a transrectal probe was developed and used to treat canine prostates in a formal study to determine whether or not this technology could be used to treat human benign prostatic hypertrophy. Next, after FDA approval, 15 patients were treated at Indiana University in the fall of 1992. Both canine and human studies have shown that high-intensity focused ultrasound administered via a transrectal probe is capable of creating prostate lesions without injury to intervening and surrounding tissue.

Animals↗

PubMed1998

Transcutaneous high-intensity focused ultrasound and irradiation: an organ-preserving treatment of cancer in a solitary testis.

OBJECTIVES: The aim of this study was to determine the feasibility and safety of transcutaneous ablation of human testicular tissue by high-intensity focused ultrasound (HIFU). METHODS: Transcutaneous ablation of human testicular tissue by HIFU was performed with equipment previously developed for transrectal prostate ablation. This device utilizes a piezoceramic transducer operating at 4.0 MHz with a site-intensity of 1,600-2,000 W/cm2. To study the histological impact of transcutaneous HIFU, tests of 4 patients with prostate cancer were subjected to transcutaneous HIFU-therapy prior to scrotal orchiectomy in a phase I trial. In a phase II clinical trial, 4 patients with the typical sonographic pattern of a tumor in a solitary testis were treated with transcutaneous HIFU as a minimally invasive organ-preserving approach followed by a 6 weeks' course of prophylactic irradiation of the testis with 20 Gy. In all 4 patients, the contralateral testis had been previously removed for testis cancer. RESULTS: Histologically, HIFU-treated areas exhibited signs of cellular necrosis in all cases (n = 4). The border between viable and necrotic tissue was extremely sharp comprising only 5-7 cell layers. In the phase II clinical study, we aimed to ablate the entire cancer in a single therapeutic HIFU session. HIFU treatment was performed under general anesthesia. As negative side effects we observed a cutaneous thermolesion in 1 individual. One patient refused to undergo postoperative irradiation and developed a local failure. This patient underwent radical orchiectomy. Another patient received two cycles of chemotherapy for a single suspicious retroperitoneal lymph node diagnosed 6 months after HIFU therapy. Three patients are tumor-free with a follow-up of 16, 23 and 31 months, respectively. CONCLUSIONS: This study demonstrates the feasibility and safety of transcutaneous testicular tissue ablation by HIFU. Despite the major drawback of this technique, i.e. that no tumor histology is obtained, we believe that transcutaneous HIFU followed by irradiation has the potential to be established as a minimally invasive treatment alternative to organ-preserving surgery for tumors in a solitary testis.

Adult↗

PubMed2003

Effect of split-focus approach on producing larger coagulation in swine liver.

The split-focus approach has the potential to substantially improve the throughput of coagulation high-intensity focused ultrasound (HIFU) treatment. A prototype split-focus transducer with four elements at 4.25 MHz, combined with a small imaging probe at 6.5 MHz, was constructed for transrectal treatment of a prostate. Computer simulation predicted that 1.57 times larger acoustic power than a single-spot focus was required for a split focus to heat the tissue up to the same peak temperature at 4 s from the start of insonation. When the peak temperature was 100 degrees C, the tissue volume above 70 degrees C was predicted to be 2.3 times larger for a split focus. Swine liver lobes were intraoperatively insonated with the split-focus transducer for 4 s. A lesion of coagulation necrosis 3 to 4 times larger in volume than with a single-spot focus was formed with a split focus at the same acoustic power ratio as described above. Furthermore, a lesion about 2 times larger in volume was formed when compared at the same acoustic power. These results show the great advantage of a split-focus approach over a conventional single-spot focus in coagulation treatment.

Animals↗

PubMed1994

High-intensity focused ultrasound in the treatment of prostatic tissue.

OBJECTIVE: Beginning in 1987, high-intensity focused ultrasound was investigated in the canine model to determine the feasibility of destroying prostate tissue. After demonstrating the ability to ablate prostate tissue reliably in a canine model, a 15-patient pilot clinical study was undertaken at Indiana University in the fall of 1992. This pilot study was undertaken to assess the safety in the human clinical situation, as well as to give some early efficacy results. METHODS: The early canine feasibility studies were conducted via a suprapubic extracorporeal approach using two separate transducers, one for imaging and the other for therapy. Subsequent to this, a transrectal probe, which had the dual capability of both imaging and therapy, was developed and used to treat canine prostates in a formal, "good laboratory practice" study to determine the safety of this technology prior to beginning treatment of human benign prostatic hypertrophy. RESULTS: The formal canine studies demonstrated that prostatic tissue could be reliably ablated in the therapy zone. The dosimetry and duty cycle required to ablate canine prostatic tissue effectively was also determined in this study. The study also demonstrated that the prostatic tissue could be ablated without injury to the intervening rectal tissue or periprostatic tissue. The human pilot study has also demonstrated safety of high-intensity focused ultrasound, as well as early efficacy. CONCLUSIONS: These early clinical results are encouraging, but assessment of efficacy will require a randomized study comparing high-intensity focused ultrasound to sham and to transurethral prostatectomy. This multicenter trial is currently planned.

Animals↗

PubMed1997

High-intensity focused ultrasound in the treatment of benign prostatic hyperplasia.

OBJECTIVE: To assess the role of high-intensity focused ultrasound (HIFU) in the treatment of symptomatic benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Thirteen patients (mean age 65 years, range 58-74) were treated with HIFU as part of a phase-2 clinical trial and evaluated prospectively using the International Prostate Symptom Score, uroflowmetry, and transrectal and transabdominal ultrasonography to determine prostate size and post-void residual urine volume, respectively. The results and the patients' satisfaction were assessed at regular intervals for 2 years. RESULTS: The new procedure was learned quickly and was easy to perform. Symptom scores decreased from a mean of 23 before treatment to 5 after 12 months and 7 after 2 years. There was an initial improvement in flow rates but they then declined. The size of the prostate and the post-void residual volume were both decreased after treatment. CONCLUSIONS: The treatment is safe, easy to implement and was effective in substantially reducing symptom scores in these few patients. However, we would not encourage its use as an alternative to other well established treatment modalities until it has been assessed fully in a randomized trial.

Aged↗

PubMed1996

Noninvasive ultrasonic subtotal ablation of the prostate in dogs.

OBJECTIVE: To determine whether high-intensity focused ultrasound (HIFU) can be used for subtotal ablation of the prostate gland in dogs without causing damage to surrounding tissues. DESIGN: Experimental trial. ANIMALS: Adult hounds > or = 5 years old and weighing between 20 and 30 kg. PROCEDURE: Prostatic ablation was performed in all dogs, using a transrectal HIFU probe. Acute effects of HIFU treatment were evaluated in 4 dogs. These dogs were euthanatized and necropsied 4 hours after the procedure. Chronic effects were evaluated in the other 3 dogs. Serial CBC, serum biochemical analyses, urinalyses, and transrectal ultrasonography were performed. Dogs were euthanatized and necropsied 3 months (1 dog) or 1 year (2 dogs) after HIFU treatment. RESULTS: Histologic examination of the prostate glands from the 4 dogs euthanatized 4 hours after treatment revealed that 80 to 90% of the gland had undergone hemorrhagic, liquefactive necrosis. Only slight discoloration of the prostatic capsule was detected, and there were not any gross or histologic lesions of the rectal mucosa or urinary bladder. All 3 dogs followed up after HIFU treatment developed cystic cavities within the prostate. Clinicopathologic testing did not indicate any long-term adverse effects. CONCLUSIONS AND CLINICAL RELEVANCE: This method was effective in causing subtotal ablation of prostatic tissue in dogs. Further study of morbidity is required before the technique can be used clinically.

Animals↗

PubMed2001

[Therapy of local prostatic carcinoma with high intensity focussed ultrasound (HIFU). Outcome and side-effects].

At the time of diagnosis, prostate cancer is organ confined in 70% of the cases. Of these patients, 25% undergo local therapy (surgery/radiation), and 75% risk disease progression by "watchful waiting" or systemic side effects through hormonal ablation. Local high-intensity focused ultrasound (HIFU) for minimal invasive tissue coagulation (85 degrees C) ablates prostatic tissue with high precision. Follow-up sextant biopsies (1.9) showed 80% of the patients to be cancer free. In those cases with residual cancer, the tumor mass was reduced by more than 90%. The PSA nadir in 97% was < 4 ng/ml, including 61% < 0.5 ng/ml. After primary HIFU, no severe side effects occurred (no fistula, no grade II/III incontinence, no rectal mucosa burn). As auxiliary treatments, all patients received a suprapubic tube (29 days), and 33% needed a transurethral debris resection (TUR 7 g). The patients were released from the hospital within 24 h after treatment. According to the short-term follow-up, transrectal HIFU enables minimal invasive local prostate tissue ablation with high rates of negative biopsies, low PSA nadir, and low complication rate.

Aged↗

PubMed2001

Results and side effects of high-intensity focused ultrasound in localized prostate cancer.

At the time of diagnosis, prostate cancer is organ confined in 70% of the cases. A quarter of these patients undergo local therapy (surgery/radiation); 75% risk disease progression by "watchful waiting" or systemic side effects through hormonal ablation. Local high-intensity focused ultrasound (HIFU), as minimal invasive tissue coagulation (85 degrees C), ablates prostatic tissue with high precision. Since April 1996, 184 patients have undergone 232 sessions of transrectal HIFU therapy (average 90 min) under spinal anesthesia at 2.25/3.0 MHz, 50 W, and a penetration depth of 25 mm. The follow-up serum prostate specific antigen (PSA) concentration, sextant biopsies, International Prostate Symptom Score (IPSS), quality of life measures (QoL), and complaint registration provide the foundation for this clinical evaluation. Follow-up sextant biopsies (an average of 1.9) showed 80% of the patients to be cancer free. In men with residual cancer, the tumor mass was reduced more than 90%. The PSA nadir in 97% was <4 ng/mL, including 61% with values <0.5 ng/mL. After primary HIFU, no severe side effects (fistula, second or third grade incontinence, rectal mucosal burns) occurred. All patients had a suprapubic tube (average 29 days), and 33% needed a transurethral debris resection averaging 7 g. They were discharged within 23 hours. According to the short-term follow-up transrectal HIFU enables minimal invasive local prostate tissue ablation with high rates of negative biopsies, low PSA nadir, and low complication rate.

Equipment Design↗

PubMed1993

High-intensity focused ultrasound experimentation on human benign prostatic hypertrophy.

High intensity-focused ultrasound (HIFU) has been used transrectally to induce an intraprostatic coagulation necrosis lesion in human prostatic adenoma. The device to produce HIFU combines a firing system (power amplifier and therapy transducer) and an imaging system (ultrasound scanner). Nine patients have been treated on epidural anaesthesia with an ultrasound intensity similar to or higher than the acoustic intensity used in previous experiments on canine prostates. Intraprostatic lesions were obtained without any damage to the rectal wall. These lesions were also histologically determined to be coagulation necrosis with a complete destruction of the glandular tissue. These studies confirm the possibility of creating irreversible lesions in the prostatic tissue through the rectal wall. The destruction of localised prostatic cancer would seem to be possible in the near future by using HIFU delivered by the transrectal route.

Humans↗

PubMed2000

High-intensity focused ultrasound in prostate cancer: results after 3 years.

BACKGROUND: Local high-intensity focused ultrasound (HIFU) is a minimally invasive method of coagulation (85 degrees C) that ablates prostatic tissue with high precision. PATIENTS AND METHODS: Over a 3-year period, 184 patients with organ-confined prostate cancer have undergone 232 sessions of transrectal HIFU therapy (mean duration 90 minutes) under spinal anesthesia at 2.25 or 3.0 MHz, 50 W, with a penetration depth of 25 mm. RESULTS: Follow-up sextant biopsies (mean 1.9) were cancer free in 80% of patients, and in patients with residual cancer, the tumor mass was reduced more than 90%. The nadir value of prostate specific antigen (PSA) was <4 ng/mL in 97%, including 61% who had values <0.5 ng/mL. After primary HIFU, no severe side effects (fistula, grade 2 or 3 incontinence, rectal mucosal burn) were seen. All patients had a suprapubic tube (mean 29 days), and 33% needed transurethral resection of debris (mean 7 g). Hospital discharge was within 23 hours after treatment. CONCLUSION: Transrectal HIFU enables minimally invasive local prostate tissue ablation with high rates of negative biopsies, low PSA nadir, and low complication rate. Further follow-up is needed to define the efficacy of disease control.

Aged↗