bladder cancer patients eligible for cisplatin chemotherapy MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 64 Rame Cloruro
Product Code: [64Cu (II)Cl2]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: rame cloruro ( 64CuCl2)
Current Sponsor code: (64Cu)CuCl2
Concentration unit
Sponsors
ENTE OSPEDALIERO OSPEDALI GALLIERA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Anemia with Hb 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate the diagnostic accuracy of the 64CuCl2-PET / CT examination in urothelial tumors. In particular, the Detection Rate (DR) and sensitivity of this diagnostic technique will be assessed and compared with that relating to the CT examination (reference imaging method).;Secondary Objective: evaluate the role of the 64CuCl2-PET / CT examination in predicting the response to neo-adjuvant of first-line cisplatin chemotherapy;Primary end point(s): evaluate the diagnostic accuracy of the 64CuCl2-PET / CT examination in urothelial tumors. In particular, the Detection Rate (DR) and sensitivity of this diagnostic technique will be assessed and compared with that relating to the CT examination (reference imaging method).;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactS.C. Medicina Nucleare
E.O. Ospedali Galliera
Outcome results
None listed