Non-invasive nodal staging in breast cancer with MRI Lymphography using gadofosveset.

Non-invasive nodal staging in breast cancer with MRI Lymphography using gadofosveset. - Gadofosveset in breastlesions

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43763

Enrollment

160

Registered

2012-05-30

Start date

2012-08-17

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Breast cancer Lymph node metastases

Interventions

MRI of the lymph nodes in the axilla with gadofosveset contrast agent.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Female patient with histopathologically confirmed breast cancer about to undergo nodal staging. 2. Willing and able to undergo all study procedures 3. Has personally provided written informed consent;Additional inclusion criteria for 2nd axilla-MRI 1. Patient treated with neo-adjuvant therapy 2. Indication for ALND after neo-adjuvant therapy as result of regular treatment

Exclusion criteria

Exclusion criteria: 1. Age

Design outcomes

Primary

Measure	Time frame
The main study parameter will be the accuracy (sensitivity, specificity, NPV and PPV) of the MRL in predicting the involvement of metastases in the investigated lymph nodes. We will compare the results of the MRL with the pathological results of a negative SLNB or the ALND. In cases with a positive MRL and negative SLNB, we will investigate if the MRL is really wrong, or that we probably found a case of a false negative SNLB procedure.	—

Measure

Time frame

The main study parameter will be the accuracy (sensitivity, specificity, NPV and PPV) of the MRL in predicting the involvement of metastases in the investigated lymph nodes. We will compare the results of the MRL with the pathological results of a negative SLNB or the ALND. In cases with a positive MRL and negative SLNB, we will investigate if the MRL is really wrong, or that we probably found a case of a false negative SNLB procedure.

—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)