Plain English Summary
Background and study aims
The currently available imaging techniques are not accurate enough to evaluate the presence of small metastases in patients with tumours of the kidney, bladder, penis and prostate. The aim of this study is to find out how the images obtained from a PET/CT scan with a new tracer “drug” (64CuCl2) compare with the actual tumours removed during surgery.
Who can participate?
Patients aged over 18 with tumours of the kidney, bladder, penis and prostate who are about to undergo surgery
What does the study involve?
Participants undergo a special PET/CT scan with 64CuCl2. The images are compared with the tumours that are removed during surgery.
What are the possible benefits and risks of participating?
The special PET/CT scan may allow a better evaluation of the whole body with a single exam. The risks are minimal and are related to the use of 64CuCl2, but previous studies have not found any side effects.
Where is the study run from?
Santo Spirito Hospital (Italy)
When is the study starting and how long is it expected to run for?
January 2018 to December 2018
Who is funding the study?
Spirito Santo Hospital (Italy)
Who is the main contact?
Dr Manlio Mascia
Trial website
Additional identifiers
EudraCT number
2017-000490-17
ClinicalTrials.gov number
Protocol/serial number
2.0
Study information
Scientific title
Phase IIa clinical study of 64CuCl2: efficacy and safety of a new tracer for urologic tumors
Acronym
Study hypothesis
The aim of this study is to evaluate the diagnostic performance, the safety profile and the effectiveness of a new tracer (64CuCl2) for PET/CT scan exams in patients affected by urological tumors such as kidney, bladder, prostate and penis tumors.
Ethics approval
Not provided at time of registration
Study design
Interventional prospective single-center Phase IIa trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Urologic tumors (kidney, prostate, bladder, penis)
Intervention
A comparison between nuclear imaging (PET/CT scan) pictures and surgical pathology in patients with different neoplasms undergoing surgical excision.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
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 outcome measures
64CuCL2 PET/CT technique performance in target/background contrast (T/B), measured immediately (1-2 days) after the PET/CT scan
Overall trial start date
01/01/2018
Overall trial end date
31/12/2018
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25
Participant 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”
Recruitment start date
03/03/2018
Recruitment end date
03/07/2018
Locations
Countries of recruitment
Italy
Trial participating centre
Santo Spirito Hospital, Nuclear Medicine Unit
Via Fonte Romana, 8
Pescara
66124
Italy
Funders
Funder type
Hospital/treatment centre
Funder name
Spirito Santo Hospital, Pescara (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
After the collection and the analysis of the results at least one paper will be sent to a peer reviewed international journal after the overall trial end date.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/12/2019
Participant level data
Other
Results - basic reporting
Publication summary