NL-OMON36226招募中2 期
MR-guided focal laser ablation of the prostate: a pilot study - MR-guided focal laser ablation
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Inclusion criteria counting for both groups:
- •Newly diagnosed and biopsy proven prostate cancer
- •Low risk patients (PSA <= 10 ng/mL, Gleason 3+3, cT1c - T2a)
- •No previous treatment for prostate cancer
- •Cancer lesion located at least 2 cm away from the neurovascular bundle
- •according to Multimodality MR images
- •Signed informed consent by patient
- •Age 18 years or older
- •Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia);Additional inclusion criterion for patients in group A:
- •Patients must be scheduled for a radical prostatectomy with a lesion of max 4 cm
排除标准
- •Impossibility to obtain a valid informed consent
- •Patients unable to undergo MR imaging, including those with contra-indications
- •Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection)
- •Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
- •Patients with evidence for nodal or metastatic disease
- •Patients with an estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2
研究者
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