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
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
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