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临床试验/NL-OMON36226
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

发起方
niversitair Medisch Centrum Sint Radboud

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