Untreated squamous cell cervical carcinoma(SCCC). MedDRA version: 9.1 Level: HLT Classification code 10029109 Term: Cervix neoplasms
Conditions
Interventions
Trade Name: VASOVIST
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOFOSVESET TRISODIO
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration n
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed