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SmartTarget THERAPY

NCT02290561 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2014-11-14

No results posted yet for this study

Summary

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

Conditions

  • Prostatic Neoplasms

Interventions

PROCEDURE

SmartTarget Therapy

MRI to Ultrasound fusion directed HIFU

DEVICE

MRI

DEVICE

high intensity focused ultrasound (HIFU)

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Hashim U Ahmed, FRCS PhD · University College, London

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-10-31
Completion
2015-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02290561 on ClinicalTrials.gov