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Use of 64CuCl2 in urologic tumors

Phase IIa clinical study of 64CuCl2: efficacy and safety of a new tracer for urologic tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11735271
Enrollment
25
Registered
2017-11-21
Start date
2018-03-03
Completion date
Unknown
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urologic tumors (kidney, prostate, bladder, penis) Cancer

Interventions

A comparison between nuclear imaging (PET/CT scan) pictures and surgical pathology in patients with different neoplasms undergoing surgical excision.

Sponsors

Ospedale Civile "Spirito Santo"
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subject aged over 18 at diagnosis 2. Subject with renal or bladder or prostate or penile cancer waiting for surgical excision or imaging restaging due to progressive disease 3. Availability of already done cross-sectional imaging in the last month 4. Karnofsky index >80% 5. Absence of relevant comorbidities (see exclusion criteria) 6. Full mental ability to understand the value and the relevance of the protocol and the related procedures showed in the “Informativa per il soggetto” 7. Full mental ability in order to give informed consent 8. Negative pregnancy test for women potentially at risk for pregnancies

Exclusion criteria

Exclusion criteria: 1. Hb levels < 10 gr/dL 2. Presence of copper metabolism diseases (Menkes or Wilson diseases) 3. Previous participation in clinical trial involving ionizing radiation for diagnostic or therapeutic finality in the last year 4. Working exposition to ionizing radiation 5. Each condition that could alter and reduce the compliance of the subject to the participation to the study protocol 6. Mental inability to fully understand the “Informativa per il soggetto”

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity based on whole body PET/CT after 64CuCL2 in primitive and metastatic lesions, measured immediately (1-2 days) after the PET/CT scan

Secondary

MeasureTime frame
64CuCL2 PET/CT technique performance in target/background contrast (T/B), measured immediately (1-2 days) after the PET/CT scan

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026