Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

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

MRI to ultrasound fusion guided prostate biopsy

SmartTarget - Biopsy

The purpose of this study is to determine how well SmartTarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer.

The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the disease location. Transperineal mapping biopsies overcome this by systematically samples the entire gland but are very intensive and time consuming to perform.

An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy can be used to inform doctors about the location of the disease. This is a difficult procedure to perform as it requires the surgeon to mentally translate the location of disease on MRI image to the live ultrasound seen in theatre.

SmartTarget may help this procedure by providing guidance to the location of the disease by fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to biopsy.

This trial will compare the outcomes of "visually directed biopsies" with those directed by SmartTarget

SmartTarget: BIOPSY

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

The proportion of men with clinically significant disease based on SmartTarget guided biopsy compared to the proportion of men with clinically significant disease based on visually-directed biopsy.

The targeting efficiency of the SmartTarget guided biopsies versus visually-directed biopsies measured by:

Number of cores required to obtain the highest cancer risk category Number of cores with cancer Maximum Cancer Core Length and Total Cancer Core Length Highest Grade Cancer

To evaluate the clinical usability of SmartTarget guided biopsy as measured by:

Length of Procedure SmartTarget model generation time SmartTarget re-registration rate SmartTarget failure rate

To assess how this biopsy strategy impacts on quality of life as measured using validated questionnaires:

IPSS IIEF EQ5D - 5L

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Automatic registration for fusion imaging of US and MRI will be performed.

Automatic Imaging fusion of ultrasonography and MRI

Manual registration for fusion imaging of US and MRI will be performed.

Manual Imaging fusion of ultrasonography and MRI

Radiofrequency ablation for hepatic malignancies will be performed with automatic registration registration. Except the imaging registration, all other procedures for RF ablation is same.

Automatic Imaging fusion of ultrasonography and MRI

Radiofrequency ablation for hepatic malignancies will be performed with manual registration registration. Except the imaging registration, all other procedures for RF ablation is same.

Manual Imaging fusion of ultrasonography and MRI

Joon-Il Choi

Fusion imaging of US and MRI is very helpful for interventional procedure such as radiofrequency ablation in liver. However, manual registration of US and magnetic resonance (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians. Recently, automatic registration function was developed to help the fusion of US and CT/MRI imaging. The purpose of this trial is to compare the registration time and accuracy of manual registration system and automatic registration system.

1. Patients will be randomized and assigned.
2. For automatic registration group, automatic image fusion will be done by RS80A US unit and RF ablation will be performed. Image fusion time will be measured.
3. For manual registration group, manual image fusion will be done by LOGIQ-E9 US unit and RF ablation will be performed. Image fusion time will be measured.

3) After radiofrequency (RF) ablation, immediate, contrast enhanced CT will be performed to evaluate technical success and complications 4) Accuracy of registration will be measured by home-made software using 3D techniques.

5) After one month, technical effectiveness will be evaluated by contrast enhanced CT 6) F/U of CT images will be obtained until one year after RF ablation with a interval of 1-3 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SmartTarget THERAPY	NCT02290561	Prostatic Neopl...	SmartTarget The... MRI high intensity ...	-	University College, London
SmartTarget: BIOPSY	NCT02341677	Prostatic Neopl... Diagnostic Tech...	SmartTarget - B...	-	University College, London
Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of Hepatocellular Carcinoma	NCT02705118	Hepatocellular ...	Automatic Imagi... Manual Imaging ...	40 Years -	Seoul St. Mary's Hospital

Spots Global Cancer Trial Database for image fusion

Every month we try and update this database with for image fusion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.