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

Phase 4

Conditions: lymph node metastasis
tumor positive lymph nodes
10006291

Registration Number: NL-OMON30564

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 440

Inclusion 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

Exclusion Criteria

- Patient age < 18
- Karnofsky score = 70 or <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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the sensitivity of MRL for proved lymph node<br /><br>involvement by histopathology on a patient to patient basis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>· Sensitivity on a node to node basis<br /><br>· Specificity, accuracy, negative predictive value and positive predictive<br /><br>value on a patient to patient and node to node basis<br /><br>· Posttest probability negative rate<br /><br>· Feasibility of MRL after SLNB<br /><br>· Diagnostic accuracy of MRL after SLNB<br /><br>· Prognostic value of IMN involvement<br /><br>· Prognostic value of positive and negative MRL after positive SLNB followed by<br /><br>irradiation of the axilla<br /><br>· Feasibility of MRL after neoadjuvant chemotherapy<br /><br>· Diagnostic accuracy of MRL after neoadjuvant chemotherapy<br /><br>· Effect of chemotherapy on tumor positive axillary lymph nodes</p><br>