Diagnostic and predictive role of 64CuCl2 PET / CT in bladder cancer patients eligible for chemotherapy - Diagnostic-predictive role of 64CuCl2 in urothelial tumors

ENTE OSPEDALIERO OSPEDALI GALLIERA0 个研究点目标入组 50 人开始时间: 2021年4月16日最近更新: 2021年4月26日

适应症

试验速览

暂无简介。

•1. Patients with invasive muscle disease (Documented by the reference of the histopathological report)
•2. Patients with metastatic disease (Documented by clinical report)
•3. Age = 50 years at the time of enrollment (There are no upper age limits that contraindicate the performance of 64CuCl2-PET / CT)
•4. Previous histological, documentable diagnosis of primary adenocarcinoma of the bladder (Documented by the reference of the histopathological report and / or clinical report)
•5. Clinical indication on staging or restaging (Documented by clinical report)
•6. MR Imaging and / or CT and / or bone scan tests no older than 30 days (Documented by clinical report)
•7. Negative clinical history for other past or ongoing neoplastic pathologies, with the exception of non-melanoma skin carcinomas (Anamnestic relief)
•8. Karnofski index = 80% (In the opinion of the Investigator)
•9. Absence of other relevant comorbidities (see: exclusion criteria, medical history)
•10. Full ability to understand the information contained in the illustrative documentation for the Subject (In the opinion of the Investigator)
•11. Full ability to sign informed consent (In the opinion of the Investigator)
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1. Anemia with Hb <9 gr / dL (Laboratory data)
•2. Presence of symptoms or signs of sepsis and / or evidence of acute infections (In the opinion of the investigator)
•3. AST> 1.5 times the upper limit of the normal range (laboratory data)
•4. ALT> 1.5 times the upper limit of the normal range (Laboratory data)
•5. Total bilirubin> 1.5 times the upper limit of the normal range (laboratory data)
•6. Copper metabolism diseases (Menkes disease, Wilson disease, anamnestic relief)
•7. Any condition, material, logistics, or Subjective, which, even in the opinion of the Principal Investigator, may condition the compliance of the Subject to the execution of the procedures set out in the Protocol (In the opinion of the Investigator)
•8. Inability to understand the content of the information documentation for the Subject (In the opinion of the Investigator)

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