Exploratory study to evaluate different MRI-contrast-agent-application-schemes using Gadovist to optimize contrast enhancement for longer lasting breast examination - Contrast agent application scheme

• Conditions: Patients with recent diagnosis of breast cancer, histologically proven.; MedDRA version: 12.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2010-018862-22-DE
• Lead Sponsor: Kliniken Essen-Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-09
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) Adult patients, age 18 years and older
2) with recent diagnosis of breast cancer, histologically proven (within the last 6 weeks before inclusion)
3) referred to contrast-enhanced MRI of the breast for clinical reasons before surgery
4) willing and able to comply with and complete all study procedures
5) who provided written informed consent voluntarily and in person
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) If female, being pregnant or in nursery (females of childbearing potential must have a negative urine pregnancy test at the day of MRI prior to administration of gadobutrol
2) Any contraindication to the MRI procedure (e.g., metal implants, phobia)
3) Any contraindication to gadolinium-containing MR contrast agents
4) History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
5) Having received any contrast agent within 24 hours prior to the MRI examination planned in this study
6) Considered to be clinically unstable or risk of unpredictable clinical course during the study period (e.g., due to previous surgery, acute renal failure)
7) Severe cardiovascular disease (e.g., known long QT syndrome, acute myocardinal infraction [<14 days], unstable angina, congestive heart failure NYHA class IV) or acute stroke (<48 hours)
8) Severly or moderately impaired renal function (GFR calculated with MDRD formular 9) Scheduled or likely to require surgery and/ or biopsy before MRI or within 24 hours after study drug administration
10) Participating in another diagnostic clinical trial
11) Having previously entered this study
12) Patients with a heart rate > 100/ min (measured before the MRI examination)
13) Patients with a blood pressure > Systole/ Diastole 200/ 100 mmHg (measured before the MRI-examination)

Study & Design

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