Higher diagnostic accuracy of 64Cu PET/CT compared to standard 18F-choline PET/CT in the detection rate of metastasis from prostate cancer.Phase III multicenter, sponsored, interventional open-label clinical study, with prospective enrollment. - 64CuCl2 PET/CT VS 18F-choline PET/CT in prostate cancer

SPARKLE SR0 个研究点目标入组 111 人开始时间: 2020年10月8日最近更新: 2021年1月11日

试验速览

暂无简介。

•1.Age >=45 years at the enrollment time
•2.Documented hystologically diagnosis of PCa
•3.Clinical indication to staging or restaging
•4.Imaging of MRI and/or TAC and/or bone scintigraphy not older than 30 days
•5.Previous execution of 18F-FCH not older than 30 days
•6.Patient at risk of developing metastasis during their illness according symptoms presence or EAU criteria of risk as follows:
•At diagnosis : PSA > 20 or GS > 7 or cT2c; or any PSA –any Gs cT3-4 or cN+;
•At restaging after primary treatment: PSA > 1 ng/ml;
•After-staging for biochemical progression during treatment: 3 PSA assay demonstrating an increase > 50% respect to nadir and a PSA > 2 ng/ml.
•7.No other concomitant or previous malignant tumors, except for non-melanoma skin cancers
•8.Karnofski index ¿ 80%
•9.No other relevant disease (cfr exclusion criteria)
•10.Ability to understand the contents of the information material for the subject
•11.Ability to sign the Informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 111
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 111

•1.Anemia (Hb<9 gr/dl)
•2.Symptoms or signs of sepsis and / or evidence of acute infections
•3.AST >1.5 higher than normal range
•4.ALT >1.5 higher than normal range
•5.Total bilirubin > 1.5 higher than normal range
•6.Copper metabolism disease (m.di Menkes, m.di Wilson)
•7.Previous participation in trials with exposure to ionizing radiation for therapeutic purposes
•8.Any condition, material, logistics, or Subjective, which, even in the opinion of the Principal Investigator, may condition the subject's compliance with the execution of the procedures established by the Protocol
•9.Inability to understand the contents of the information documentation for the subject

发起方

SPARKLE SR