跳至主要内容
临床试验/ACTRN12616000186459
ACTRN12616000186459已完成3 期

Feasibility study – Identification of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy

Queensland University of Technology0 个研究点目标入组 30 人开始时间: 2016年2月12日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
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
分配方式
Non-randomised trial
主要目的
Diagnosis
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
Male

入选标准

  • 1.Male patients with pathologically diagnosed prostate cancer
  • 2.Biochemical Recurrence as defined:
  • a.PSA > 0.2ng/ml on at least 2 occasions post radical prostatectomy
  • b.PSA 2.0ng/ml above nadir 2 years post radiotherapy
  • 3.History of primary treatment for prostate cancer no sooner than 3 months post-surgery and 2 years post radiotherapy
  • 4.No known problems with peripheral intravenous or central line access
  • 5.Able to provide informed signed consent

排除标准

  • 1.Age under 18 years
  • 2.Administered a radioisotope within 5 physical half-lives prior to study enrolment
  • 3.Unable to lie flat during or unable to tolerate PET/MRI
  • 4.Prior history of any other malignancy within last 2 years
  • 5.Contraindication to PET scan or [68Ga]Gallium-labelled PSMA ligand
  • 6.Claustrophobia not manageable by oral sedatives i.e. Temazepam
  • 7.Renal impairment or haemodialysis.
  • 8.Contraindication to biopsy of identified lesion
  • 9. Contraindication to MRI such as implantable medical devices
  • 10. Body weight above 150kg or axial diameter larger than 60cm

研究者

相似试验