Vezi documentul

SME / Association / Researcher profile form

Date (dd/mm/yyyy): Profile valid until (dd/mm/yyyy):

Section 1 - Contact details

Organisation Name (full name)

Seconda Università degli Studi di Napoli Contact person:

Organisation acronym(Abbreviation)

S.U.N. Title Prof.

Address Viale Beneduce n.10 First Name RobertoPostal code 81100 Family Name GRASSI

City CASERTA Telephone 0815665203Country ITALIA Fax 0815665202www address www.unina2.it E-mail [email protected]

Section 2 – Type of organisation

If you are an Enterprise

Enterprise type Private Non profit

Public Other

Is your Company a Small-Medium sized Enterprise (SME)?

YES NO

if YES,Number of Employees

< 10 > 10 and < 50 < 250

According to Article 2 of the annex of Commission Recommendation 2003/361/EC of 6 May 2003, which applies from 01 January 2005, an SME (Micro, Small or Medium-sized Enterprise) is an enterprise which:• has fewer than 250 employees, • has an annual turnover not exceeding 50 million euro, and/or • an annual balance-sheet total not exceeding 43 million euro.http://europa.eu.int/comm/enterprise/enterprise_policy/sme_definition/index_en.htmOwned by a non SME: YES NO

Description of the organisation (max 1.000 characters):

If you are an Association

Associationtype

SME Industrial

Cultural Civil society

Other:

Sector of activity

Description of the association (max 1.000 characters):


If you are a Research Organisation

Research Organisation type

Research Organisation ( Private Public)

High Education School / University / Institute ( Private X Public)

Other, please specify: Description of the organisation (max 1.000 characters):

• Department of internistic and experimental clinic “F. MAGRASSI” and “A. LANZARA”. Director : Prof. Camillo Del Vecchio Blanco. Scientific division of Radiology, Radiotherapy and Nuclear Medicine. Director : Prof .Antonio Rotondo (MED/36 )

• Department of anesthesiologic and surgical sciences of emergency. Director : Prof. Umberto Parmeggiani . Laboratory of Biotechnologies Applied to the Medical -Surgical Sciences .

Director: Prof. Alfonso Barbarisi (MED/18)

• Laboratory of Biotechnologies A.O.R.N. “ Antonio Cardarelli”

• Institute “ Mario Negri” Milano

• Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola-Malpighi, Bologna (MED/36)

In our study will be observed , in vivo , the eventual adverse effects of Gadolinium-based contrast agents on rats’ s tissues . We will use MRI contrast agents normally use for human diagnostic investigation.We Will administer the growing non-lethal doses of gadolinium –based contrast media to rats, more precisely Omniscan (Gadodiamide).The eventual lesions found on the rats during the controls effect after administration gadolinium-based contrast agents will come studied , undergoing anesthesia , with the following diagnostic techniques :Micro- US : this technique will be used once time every month.Micro-CT, microcomputed tomography: used once time every 6 months.Micro-MRI: used once time every 3 months. (Department of internistic and experimental clinic “F. MAGRASSI” and “A. LANZARA” Director : Prof. Camillo Del Vecchio Blanco. Scientific division of Radiology, Radiotherapy and Nuclear Medicine. Director : Prof .Antonio Rotondo);Small animal PET: performed at day 7,14,21,28, 35 days after gadolinium administration and monthly afterwards. (Nuclear Medicine, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola-Malpighi, Bologna ).In particular, the tissues obtained through the bioptic sample will come analyze through ESEM (Laboratory of Biotechnologies Applied to Medical-Surgical Sciences of SUN –Director: Professor Alfonso Barbarisi).Finally results obtained by the Institute “ Mario Negri” Milano will perform a statistical analysis.

Section 3 – Sector of interest


FP7 Programme

X Cooperation ealth (Click for choosing the Theme)

Ideas

People

Capacities (Click for choosing type of programme)Further information on the sector of interest(max. 500 characters)

Research topic according to the work programme

Section 4 - Description of your expertise

Description of the expertise (max 2.000 characters)

The scope of our study is the valuation of cytotoxicity of Omniscan, a gadolinium-based contrast agents through “ in vivo” experiments on rats affect from renal insufficiency. The studies will carry out with the aim to document the possible association between the use of the gadolinium and the development of disturbs and damages of kidney, skin and/or other organs. In particular, it will analyze the eventual relationship between the insurgence of NFS and the administration of the gadolinium –based contrast agents.The experiments will have the duration of one year ( January 2008 / December 2008).In this experiment we will administer to the rats , at predefined intervals of time, the Omniscan (GE HEALTHCARE Srl) ,in different and crescents not lethal doses. Successively we will proceed with periodic controls in order to estimate the eventual presence of damages on organs and tissues of the rats.The structures interested from the eventual adverse reactions will be studied with specific diagnostic examination: micro-CT, micro-RMI , micro-US and small animal PET. On the areas interested from such lesions we will be proceed with bioptic sample and with successive histological analysis . The tissues under investigation will analyze with the ESEM (environmental scanning electron microscope). Design of study : The rats will be 80 of number , divided in 8 subgroup, each one of 10 animals Within each group, the animals will be randomised to receive one dose of contrast media out of the following:

- 0.1 mmol/kg b.w.- 0.2 mmol/kg b.w.- 0.3 mmol/kg b.w.- 0.4 mmol/kg b.w.

Thereafter they will be followed-up for each one group in order to assess the incidence of NSF.Statistical methods


We assume that NSF will occur in approximately 5 % in percent of rats with renal insufficiency treated with the standard dose ( 0.1 mmol/kg b.w.) of contrast media. This percentage is expected to increase at higher doses. Based on these assumptions, it will be necessary to obtain at least 80 evaluable rats, 40 controls and 40 with renal insufficiency, evenly distributed in each dose level (20 at 0.1 mmol/kg b.w., 20 at 0.2 mmol/kg b.w., 20 at 0.3 mmol/kg b.w. and 20 at 0.4 mmol/kg b.w.) in order to have a power of 80% to detect an effect of the presence of renal insufficiency (cases vs controls) and dose levels, with a type I error of 5%, for a bilateral test. The analysis will be performed by means a logistic regression model, including group, dose levels and their first interaction term.

Keywords describing the expertise offered (if needed more than one)

1. NSF2. Gadolinium-based paramagnetic contrast agents;.

3. MICRO-CT; MICRO-RMI; MICRO-US;SMALL ANIMAL PET;

ESEM

Section 5 – Your previous experience in FP projects

Former participation in FP European projects? YES NO

If YES Please choose

Project title: Acronym:

Activities performed Research Demonstration Training

Technology Dissemination Management

Other:

Please describe briefly

(max. 700 characters):

Section 6 – Expectations

Term commitment Short (< 1 year) Medium (1 to 3 years) Long (more than 3 years)

Commitment offered Research Demonstration Training

Technology Dissemination Management

Other: Proposed role in the project

Coordinator Work package leader Partner

Other role: Expected results for your organisation

We intend to assess through the different techniques for diagnostics for images and nuclear medicine whether there


(max 500 characters) is really a correlation between the NSF and the administration of gadolinium-based contrasts media in rats suffering from renal insufficiency. Also from this study also intend to check what is the importance and effect of the dose of contrast medium administered.

Section 7 – International cooperation

Are you interested in international cooperation? YES NO

If YES,please specify the geographical area(s) of interest

Mediterranean area Balkan area Russia and NIS (Newly independent States) Asia Africa South America Other:

I agree with the publication of my data

Please fill in the form and send to: ricercapartner@apre

Vezi documentul

Health & Medicine

Transcript of Vezi documentul