Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Uterine Neoplasms

Endometrial Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Vulvar Diseases

Vaginal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Vaginal Cancer

Vulvar Cancer

Investigating whether it would be possible to use the MRgHIFU system to treat recurrent gynaecological cancers.

Testing whether MRgHIFU could be an effective treatment for the symptoms of recurrent gynaecological cancers (pain and bleeding)

Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)

The primary objective of this pilot study is to determine whether or not it is feasible to use MRgHIFU to treat symptomatic (pain, bleeding) recurrent pelvic malignancy with an acceptable safety profile when conventional treatment options are not available. The ultimate goal is to be able not only to offer a viable method of symptom palliation in patients with recurrent pelvic tumours and improve their quality of life; but also to control tumour growth and extend life in a group of relatively young patients with isolated local recurrence.

MR-HIFU for Recurrent Gynaecological Cancer

Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU): A Feasibility Study for Treating Recurrent Gynaecological Malignancies

Institute of Cancer Research, United Kingdom

Professor of Translational Imaging

Adenocarcinoma

Prostatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to Prostatectomy. Prostatectomy consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care.

Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to HIFU. HIFU consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care.

A foley catheter is inserted on the sterile field. A suprapubic midline incision is made and the da Vinci SP surgical system is docked percutaneously directly to the bladder. Prior to the operation, a radiologist identifies and segments tumors and the urethra. A transrectal ultrasound probe is inserted and secured into a fixed position. The Koelis software is utilized to fuse MRI and ultrasound images to identify the target lesion in real-time, allowing for intraoperative guidance. The ultrasound probe rotates automatically, allowing for localization of the tumor intraoperatively. Then depending on the area of the tumor, a Hemi or quadrant resection is completed while preserving the nerves, vas deferens, and seminal vesicles. The urethrovesical anastomosis is then performed.

Transvesical Single Port Robotic Partial Prostatectomy

Three contoured measurements are required for the MR fusion system to reproduce the volume of the prostate. Following this, the area to be targeted will be selected in graded fashion from the anterior to posterior of the prostate. Once planning of ROI (region of interest) is complete, the HIFU treatment may begin. Quadrant or hemi ablation will be performed based on the size and complexity of the tumor. The distal margin of the ablation will be kept at least 4 mm away from the external sphincter. The rectal temperature and its distance from the probe will be carefully monitored throughout the procedure.

High-intensity focused ultrasound (HIFU)

Jihad Kaouk, MD

This study aims to compare the novel single-port robotic partial prostatectomy to High-intensity focused ultrasound (HIFU) in patients with low to intermediate risk localized prostate cancer. These interventions have become acceptable focal therapies prevalent with beneficial oncologic outcomes and therefore need to be examined further.

The primary objective is to evaluate the in-field recurrence rates and recurrence free survival - defined as the absence of clinically significant prostate cancer within the treated zone (identified by prostate MRI and subsequent targeted prostate biopsy).

Secondary objectives of interest are:

* Perioperative parameters such as operative time, perioperative complications, analgesic requirement, postoperative hospital stay, foley catheter duration
* Functional outcomes such as time to urinary continence, urinary continence, and erectile dysfunction
* Oncologic outcomes such as biochemical recurrence rates (defined in section 2.1), recurrence free survival, presence of secondary intervention for prostate cancer (HIFU, radiation, surgery, ADT)

Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)

Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy

Minutes from incision to closing during surgery (median)

Clavien-dindo classification number (1-5), number (percent)

Units of oral morphine equivalent dosing (mg), median

Time that patient is observed in the hospital after surgery, in hours (median)

Time at which the foley catheter is removed after treatment, in days (median)

Time at which the patient becomes continent in days (median)

Continence defined as using 1 pad for security or less for stress urinary incontince, recorded as yes or no (percent)

Assessed using scores from a validated survey (IIEF-5). Recorded as the the score from 5 (impotent) to 25 (no impotence), median.

PSA recurrence defined as PSA nadir after treatment +1ng/ml within 12 months or PSA Nadir + 1.5ng/ml from 12-36 months. Recorded as yes or no (percent)

Time point at which the patient undergoes treatment for prostate cancer recurrence

Case Comprehensive Cancer Center

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Dermatologic Agents

All Drugs and Chemicals

Coal Tar

SmartTarget Therapy

high intensity focused ultrasound (HIFU)

Ian A Donaldson, BMBS MRCS

Hashim U Ahmed, FRCS PhD

The purpose of this study is to assess how accurately SmartTarget can direct high intensity focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate.

The current standard methods for treating prostate cancer are directed to the whole gland - either surgery to remove it or radiotherapy. An alternative method is focal therapy. This is surgery that uses an energy source to ablate the cancer whilst preserving the normal healthy tissue.

Prior to surgery prostate cancer can often be localised using MRI imaging and detailed prostate biopsy techniques. The difficulty is that during surgery it is very difficult to accurately locate the cancer on the live ultrasound images - to compensate surgeons will treat half or a quarter of the prostate to ensure that the cancer is treated. This may cause higher rates of side-effects.

SmartTarget is an MRI to ultrasound fusion device that maps the pre-treatment MRI onto the live ultrasound during surgery. It then provides a target for the surgeons to treat during the operation.

The results will measure if the area intended to treat was covered and if how accurate the treatment was by comparing the pre-treatment MRI with a 1 week post treatment scan

SmartTarget THERAPY

SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Therapy

The ability of SmartTarget-directed focal HIFU therapy to ablate an intended target within the prostate, as measured by the proportion of men in whom complete ablation of the target region is achieved. Complete or incomplete ablation is determined by a comparative assessment of the pre-therapy and one week post-therapy contrast-enhanced MRIs by an expert radiologist.

The accuracy of SmartTarget guided focal HIFU measured by the relative treatment volume and relative ablation volume on the one week post treatment.

The efficiency and clinical usability of the SmartTarget device as measured by the:

Length of the procedure

The time taken during the procedure using SmartTarget, including:

The total prostate computer model generation time The total time taken to register (fuse) MRI and ultrasound image data and the number of times an image registration is performed using SmartTarget (the re-registration rate) SmartTarget failure rate

To assess how this treqatment strategy impacts on quality of life as measured using validated questionnaires at 6 weeks and 3 months post treatment.

IPSS IIEF EQ5D - 5L

University College, London

Neoplasm Metastasis

Pain

Neoplastic Processes

Nandita deSouza, Professor

The aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device for the palliation of pain in patients with bone metastases.

Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses ultrasound to palliate pain caused by bone metastases. The main palliative mechanism of the method is due to local bone denervation, caused by the heat denaturation of the periosteum layer in the treated area. The importance of this therapy is that it offers a non-invasive, focal therapy, avoiding side-effects to surrounding normal tissue that occur with radiation therapy or the need for needle insertion as with radio-frequency(RF)ablation.

The study hypothesis is that MR-HIFU will be effective in treating the pain associated with bone metastases

MR-HIFU for Bone Metastases

Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study

Philips Medical Systems

Musculoskeletal Diseases

Blood and Lymph Conditions

Bone Neoplasms

Bone Marrow Diseases

Bone Diseases

Hematologic Diseases

Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases

MRgHIFU treatment will be delivered using a Philips Sonalleve system, which integrates a high intensity phased array focused ultrasound transducer with our Philips 3T Achieva imaging system. An electromechanical transducer positioning system is used to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively. The MR system is used to provide images to plan the therapy, and to guide and monitor the thermal ablation with thermal imaging during the treatment.

The primary objective of this study is to determine whether intra- and post-procedural MR changes are indicative of reduction in pain symptom scores. The trial will recruit a cohort of patients with painful bone metastases, who wish to consider MRgHIFU treatment. These patients will be identified in conjunction with the pain and palliative care teams, as well as clinical and medical oncologists. Patients will undergo MRgHIFU treatment using scanning and treatment planning methods that have been established in the patients treated within the multi-centre study. The treatment response rate for the cohort will be recorded. Intra- and post-procedural imaging metrics will be evaluated for their ability to detect tissue changes, which may be indicative of response. Patients will be followed-up for up to 90 days after treatment, and will attend for repeat imaging and pain review at days 30, 60 and 90 after treatment. Any changes in imaging metrics will be compared between responders and non-responders.

The primary aim of this study is to investigate whether the ablated tissue volume indicated by immediate post-treatment Gd-T1W imaging is indicative of reduction in pain scores (response) 30 days after treatment.

The secondary aims of this study are:

* To record the proportion of patients responding to MRgHIFU treatment at Days 7, 14, 30, 60 and 90 after treatment
* To investigate whether intra-procedural PRFS metrics (thermal dose volume, temperature) are indicative of subsequent treatment response
* To investigate whether intra- or post-procedural changes in ADC or T2 are indicative of subsequent treatment response
* To record adverse events arising as a result of MRgHIFU treatment
* To evaluate the effect of MRgHIFU treatment on patients' quality of life
* To record the time to pain progression and the duration of pain response for patients in this cohort
* To estimate the costs of MRgHIFU treatment

This is an exploratory study, which will recruit n=15 patients into one single cohort. Enrolment of the target population for the study is expected to take approximately 2 years. Patients will be eligible for the study if they wish to consider MRgHIFU treatment for pain palliation of a region of bony metastatic disease that is accessible to the MRgHIFU device. After providing their written informed consent to participate in the study, patients' suitability for treatment will be determined by a combined assessment of clinical review by a pain specialist, and an MR screening investigation to establish lesion targetability. Baseline clinical and imaging metrics will be recorded. Patients who fulfill all inclusion criteria, have none of the exclusion criteria, and who give informed consent, will be scheduled for MRgHIFU treatment to the target lesion. Treatment will be delivered under sedation on a day-case basis, according to protocols already established in our prior study. During treatment delivery, the investigators will assess imaging metrics of tissue change, which may be indicative of subsequent treatment response. Treatment would be expected to take approximately 1-2 hours, and after an observation period of approximately 2-4 hours, the patient will be discharged. Before discharge, follow-up instructions will be given to the patient. Patients' clinical and imaging responses to treatment will then be assessed at follow-up appointments up to 3 months after treatment.

Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases

PRFS Metrics include thermal dose volume, temperature

using EORTC (European Organization for Research and Treatment of Cancer)- QLQ's

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MR-HIFU for Recurrent Gynaecological Cancer	NCT02714621	Cervical Cancer Endometrial Can... Uterine Cancer Ovarian Cancer Vaginal Cancer Vulvar Cancer	Magnetic Resona...	18 Years -	Institute of Cancer Research, United Kingdom
Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound	NCT05610852	Prostate Adenoc... Prostate Cancer	Transvesical Si... High-intensity ...	19 Years -	Case Comprehensive Cancer Center
SmartTarget THERAPY	NCT02290561	Prostatic Neopl...	SmartTarget The... MRI high intensity ...	-	University College, London
MR-HIFU for Bone Metastases	NCT01964677	Cancer Bone Metastases	Magnetic Resona...	18 Years -	Institute of Cancer Research, United Kingdom
Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases	NCT03479151	Cancer Bone Metastases	Magnetic Resona...	18 Years - 80 Years	Institute of Cancer Research, United Kingdom

Spots Global Cancer Trial Database for high intensity focused ultrasound (hifu)