MRI of regional lymph nodes in cT1-3N0 breast-cancer patients and DCIS (cTisN0) patients

Completed

Conditions: breast cancer
mammary carcinoma
10027476

Registration Number: NL-OMON41917

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

Female gender; >18 years old; breast-cancer patient or DCIS patient; if breast-cancer: stage T1-3 tumour, i.e. tumour of any size without direct extension to the skin; no pathologically enlarged lymph node(s) at clinical inspection (cN0), i.e. ultrasound and/or fine-needle aspiration; scheduled for sentinel-node biopsy; has given written informed consent

Exclusion Criteria

Legal incapability; previous surgery of axillary and/or supraclavicular region; previous neo-adjuvant systemic treatment; adjuvant systemic therapy prior to radiotherapy course; immediate reconstruction of the breast after mastectomy; previously known inability to maintain the scanning position (supine with arms in abduction) for 30 minutes; MRI exclusion criteria of the MRI safety group of Radiology (UMC Utrecht); not meeting the inclusion criteria

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the number of regional LNs detected in<br /><br>pre-sentinel-node biopsy (SNB) and post-SNB MRI scans, taking into account the<br /><br>number of LNs excised during SNB. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameter is the number of LNs visible on the standard CT<br /><br>scan that is used for RT planning, in comparison with the pre-SNB and post-SNB<br /><br>MRI scans. Another study parameter is the number of patients who are able to<br /><br>cope with the scanning procedure; this is monitored for all participants. The<br /><br>coping ability for scanning (pre-SNB and post-SNB) determines continuation of<br /><br>the study or the need for adaptation of the scanning protocol. </p><br>