Assessment of HIFU-induced Prostate Necrosis With Shear-wave Ultrasound Elastography (IDITOP-1)

October 21, 2014 updated by: Hospices Civils de Lyon

Transrectal Prostate Cancer High-Intensity Focused Ultrasound Ablation: Assessment of Tissue Destruction With Shear-wave Ultrasound Elastography

Transrectal High-intensity Focused Ultrasound (HIFU) is a minimally-invasive therapy for prostate cancer that is currently assessed in two indications: as a first-line treatment (either total or focal) for patients who are not eligible for surgery and as a salvage treatment of local recurrences after radiotherapy.

It has recently been shown that Contrast-Enhanced Ultrasound (CEUS) can accurately assess the position and volume of tissue destruction at the end of prostate HIFU ablation. This can provide live feedback regarding the amount of residual non ablated tissue after HIFU treatment, which could allow immediate re-treatment in case of unsatisfactory result.

CEUS requires the injection of micro-bubbles of sulphur hexafluoride (Sonovue, Bracco, Milan, Italy) which can, at least in theory, interfere with HIFU treatment. Therefore, it is necessary to wait 20 to 30 minutes before re-treating the patient.

Shear-wave ultrasound elastography (SWUE, Supersonic Imagine, Aix-en-Provence, France) can quantify tissue stiffness. Moreover, post-HIFU necrosis is known to be stiffer than undestroyed prostate tissue. Therefore, SWUE could be an alternative to CEUS, and the purpose of this study is to evaluate the accuracy of SWUE in depicting the position and volume of therapeutic necrosis after prostate cancer High-Intensity Focused Ultrasound (HIFU) ablation.

The present study is an exploratory, monocentric, prospective, descriptive study. Three groups of 10 patients with prostate cancer will be evaluated: patients referred for first-line prostate HIFU ablation, patients referred for first-line HIFU hemi-ablation (focal treatment) and patients referred for salvage HIFU after radiotherapy.

SWUE will be obtained the day before HIFU ablation (D-1), immediately after HIFU ablation (D0) and the following day (D+1). CEUS will be performed immediately after HIFU ablation and D0 SWUE.

The primary endpoint is the comparison of the thickness of undestroyed parenchyma measured by SWUE and CEUS.

The secondary endpoints are:

  • The evolution of shear elasticity within the treated area measured by SWUE at D-1, D0 and D+1,
  • Adverse events related to SWUE.

The study will last 40 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hospices Civils de Lyon - Hôpital Édouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria :

  • Age > 18 years
  • Prostate cancer proved by biopsy
  • Prostate cancer not eligible for surgery referred for total or hemi HIFU ablation, OR prostate cancer local recurrence referred for salvage HIFU ablation
  • Anal and rectal normal anatomy
  • Life expectancy ≥ 5 years
  • Satisfactory general condition (ASA 1 to 3)
  • Informed consent signed
  • Affiliation to the French social security system or equivalent social security system.

Exclusion Criteria:

  • Patient treated by hormonotherapy
  • Prostatic calcifications preventing HIFU ablation
  • Distance between rectal mucosa and prostatic capsule ≥ 6 mm
  • History of inflammatory bowel disease
  • Sclerosis of the bladder neck or urethral stenosis
  • Rectal fistula
  • Ongoing urinary infection
  • Impaired renal function (MDRD < 30mL/min/1,73 m²)
  • Severe BPCO
  • Acute endocarditis/ Hypercoagulation/ recent thromboembolism
  • Latex or sulphur hexafluoride allergy
  • Contraindication to the injection of Sonovue®
  • Patient on protection of the Court, under supervision or trusteeship
  • Inability to express an informed consent
  • Patient already enrolled in a study that could interfere with this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients referred for first-line prostate HIFU ablation
10 patients
Other: Shear-wave ultrasound elastography (SWUE)
Other: Patients referred for first-line HIFU hemi-ablation
10 patients
Other: Shear-wave ultrasound elastography (SWUE)
Other: Patients referred for salvage HIFU after radiotherapy
10 patients
Other: Shear-wave ultrasound elastography (SWUE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the thickness of undestroyed parenchyma
Time Frame: Day 0

Briefly, the thickness of undestroyed parenchyma will be measured on CEUS and D0 SWUE in the anterior, lateral and posterior parts of both prostatic lobes. The thickness (height) of undestroyed parenchyma left at both apex will also be measured.

Measurements obtained with CEUS (used as reference) and SWUE will be compared.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of shear elasticity in the treated area
Time Frame: D-1 / D0 / D+1

Using CEUS images as reference, a Region-of-Interest (ROI) will be placed within the area destroyed by HIFU in both lobes (except for the hemi-HIFU group). The stiffness within the ROI will be measured before HIFU ablation (D-1), immediately after (D0) and the day after (D+1).

One or two ROI will also be placed in undestroyed tissue (as shown by CEUS used as reference) and the evolution of stiffness from D-1 to D+1 will also be measured.
D-1 / D0 / D+1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Olivier Rouvière, Pr, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Estimate)

October 22, 2014

Last Update Submitted That Met QC Criteria

October 21, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012.730

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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