The use of USPIO enhanced MRI in the assessment of axillary lymph node status in patients with invasive breast cancer - The USPALS trial

• Conditions: The presence of axillary metastasis in patients with proven invasive breast cancer; MedDRA version: 8.1Level: LLTClassification code 10006188Term: Breast cancer female NOS

• Registration Number: EUCTR2006-006181-42-NL
• Lead Sponsor: MC St Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 440

Inclusion Criteria

nclusion criteria
- Histologically proven invasive breast cancer
- Surgical removal of at least 1 axillary lymph node will be performed
- Patient must be accessible for treatment
- Patient must provide 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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
- Patient age under 18
- Karnofsky score equal to or under 70
- Pregnant or lactating women
- Patients with conta-indications for MRI scanning (e.g. pacemaker, claustrophobia, ferromagnetic objects in the eyes or brain)
- Patients with contra-indications for the use of USPIO based contrast agents or dextran (e.g. known allergy)
- Male gender

Study & Design

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