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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41917

Enrollment

Registered

2014-11-11

Start date

2015-02-20

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer mammary carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary study parameter is the number of regional LNs detected in pre-sentinel-node biopsy (SNB) and post-SNB MRI scans, taking into account the number of LNs excised during SNB.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results