Diagnostic-predictive value of copper-64 dichloride in bladder cancer patients eligible for chemotherapy

Phase 1

• Conditions: bladder cancer patients eligible for cisplatin chemotherapy; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2019-002534-37-IT
• Lead Sponsor: ENTE OSPEDALIERO OSPEDALI GALLIERA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-16
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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