Condition category
Cancer
Date applied
15/11/2017
Date assigned
21/11/2017
Last edited
21/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Manlio Mascia

ORCID ID

Contact details

Via Istonia
1/c
Cupello
66051
Italy

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

Sponsor information

Organisation

Ospedale Civile "Spirito Santo"

Sponsor details

Via Fonte Romana,8
Pescara
66124
Italy

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes