Transrectal Prostate Cancer High-Intensity Focused Ultrasound Ablation: Assessment of Tissue Destruction With Shear-wave Ultrasound Elastography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Measurement of the thickness of undestroyed parenchyma
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
Patients referred for salvage HIFU after radiotherapy
10 patients
干预措施: Shear-wave ultrasound elastography (SWUE) (Other)
Patients referred for first-line prostate HIFU ablation
10 patients
干预措施: Shear-wave ultrasound elastography (SWUE) (Other)
Patients referred for first-line HIFU hemi-ablation
10 patients
干预措施: Shear-wave ultrasound elastography (SWUE) (Other)
结局指标
主要结局
Measurement of the thickness of undestroyed parenchyma
时间窗: 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.
次要结局
- Evolution of shear elasticity in the treated area(D-1 / D0 / D+1)