EUCTR2006-006181-42-NL
Active, not recruiting
Not Applicable
The use of USPIO enhanced MRI in the assessment of axillary lymph node status in patients with invasive breast cancer - The USPALS trial
MC St Radboud0 sites440 target enrollmentDecember 1, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The presence of axillary metastasis in patients with proven invasive breast cancer
- Sponsor
- MC St Radboud
- Enrollment
- 440
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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