Use of 64CuCl2 in urologic tumors

ISRCTN	ISRCTN11735271
DOI	https://doi.org/10.1186/ISRCTN11735271
EudraCT/CTIS number	2017-000490-17
Secondary identifying numbers	2.0

Submission date: 15/11/2017
Registration date: 21/11/2017
Last edited: 21/11/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Manlio Mascia
Scientific

Via Istonia, 1/c
Cupello
66051
Italy

Study information

Study design	Interventional prospective single-center Phase IIa trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Phase IIa clinical study of 64CuCl2: efficacy and safety of a new tracer for urologic tumors
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2018
Completion date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	25
Key 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
Key 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”
Date of first enrolment	03/03/2018
Date of final enrolment	03/07/2018

Locations

Countries of recruitment

Italy

Study participating centre

Santo Spirito Hospital, Nuclear Medicine Unit

Via Fonte Romana, 8
Pescara
66124
Italy

Sponsor information

Ospedale Civile "Spirito Santo"
Hospital/treatment centre

Via Fonte Romana,8
Pescara
66124
Italy

"ROR"	https://ror.org/01jj26143

Funders

Funder type

Hospital/treatment centre

Spirito Santo Hospital, Pescara (Italy)

No information available

Results and Publications

Intention to publish date	31/12/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
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 plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.