Differences in dynamic contrast-enhanced (DCE) MRI measurements using Magnevist (Gd-DTPA) and Vas-ovist in patients with untreated squamous cell cervical carcinoma. - ND

• Conditions: ntreated squamous cell cervical carcinoma(SCCC).; MedDRA version: 9.1Level: HLTClassification code 10029109Term: Cervix neoplasms

• Registration Number: EUCTR2008-002958-37-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Adult patients (18 years and older)
Patients willing and able to undergo all study procedures
Patients affected by untreated histologically diagnosed SCCC.
Patients who have signed the written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of severe allergic reaction or allergic reaction to MR contrast media.
Pregnant or lactating women.
Not being able to remain lying down for at least 45-60 min (e.g., patients with dyspnea at rest, severe pain at rest, severe back pain).
Patients with a contraindication to MRI such as pacemaker, aneurysm clip, or severe claustrophobia.
Uncooperative patients, in the investigator?s opinion.
Patients affected by severe renal impairment (GFR<30mL/min/1.73m2).
Patients participating in another clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary study objective is to investigate whether DCE-MRI with Vasovist is feasible and may amplify dif-ferences in Ktrans between neoplastic and normal tissues, as compared to a non blood-pool contrast agent (Magnevist);Secondary Objective: Safety evaluation;Primary end point(s): Ktrans differences