ACTRN12614000783628招募中3 期
Evaluation of Multiparametric Magnetic Resonance Imaging and Positron Emission Tomography with a [68Ga]gallium-labelled prostate-specific membrane antigen (PSMA) ligand for the Detection of Multiple Cancer Foci in Localized Prostate Cancer Patients – A Pilot Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1.Male patients pathologically diagnosed with localized prostate cancer, awaiting prostatectomy
- •2. The time interval between last prostate biopsy and planned MP-MRI or planned 68Ga- HBED-CC PET must be not less than 8 weeks
- •3. No known problems with peripheral intravenous or central line access
- •4. Able to provide informed signed consent
排除标准
- •1. Age under 18 years
- •2. Prior pelvic external beam radiation therapy or brachytherapy, prior chemotherapy, prior hormonal or radiation therapy for prostate cancer
- •3. Administered a radioisotope within 5 physical half-lives prior to study enrolment
- •4. Treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
- •5. Hemorrhagic cystitis or active prostatitis
- •6. Unable to lie flat during or unable to tolerate MP MRI or PET
- •7. Prior history of any other malignancy within last 2 years
- •8. Contraindication to MRI or MRI contrast agent or PET scan or [68Ga]gallium-labelled PSMA ligand
- •9. Claustrophobia not manageable by oral sedatives ie Temazepam
- •10. Moderate to severe rectal inflammation
- •11. Previous rectal surgery that will affect prostate imaging
- •12. MRI incompatible pacemakers
- •13. Metallic implants or pumps which are MRI incompatible
- •14. Renal impairment or hemodialysis.
研究者
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