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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006181-42-NL

Enrollment

440

Registered

2006-12-01

Start date

2007-03-15

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

The presence of axillary metastasis in patients with proven invasive breast cancer MedDRA version: 8.1 Level: LLT Classification code 10006188 Term: Breast cancer female NOS

Interventions

Product Name: Sinerem Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 9004664 Other descriptive name: IRON DEXTRAN Concentration unit: mg/ml milligram(s)/millilitre Concentratio

Eligibility

Sex/Gender

All

Inclusion 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 F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Uspio enhanced MRI (MRL) has the ability to show all lymph nodes and hence provide information on metastasis in all nodes, in contrast with SLNB which only provides information on 1 lymph node. With MRL metastases down to a size of 1 mm are detected. In 38% to 62% of patients with a positive sentinel lymph node (SLN), the SLN is the only positive node. ALND is performed in all these women and only afterwards judged unnecessary. We expect MRL to be able to identify women who have no (further) involvement of lymph nodes prior to SLNB or after a positive SLNB. Consequently ALND can be withheld from these women. MRL may also prove valuable in the 4% of patients where localisation of the SLN fails. Finally, because SLNB is false negative in 7-9% of patients, some patients are inadequately treated. MRL has a high sensitivity and provides information on all lymph nodes, consequently it may reduce the number of false negative SLNB findings. ;Secondary Objective: · Sensitivity on a node to node basis · Specificity, Accuracy, negative predictive value and positive predictive value on a patient to patient and node to node basis · Posttest probability negative rate · Feasibility of MRL after SLNB · Diagnostic accuracy of MRL after SLNB · Prognostic value of IMN involvement · Prognostic value of positive and negative MRL after positive SLNB followed by irradiation of the axilla · Feasibility of MRL after neoadjuvant chemotherapy · Diagnostic accuracy of MRL after neoadjuvant chemotherapy · Effect of chemotherapy on tumor positive axillary lymph nodes;Primary end point(s): The primary endpoint is the sensitivity of MRL for proved lymph node involvement by histopathology on a patient to patient basis	—

Measure

Time frame

Main Objective: Uspio enhanced MRI (MRL) has the ability to show all lymph nodes and hence provide information on metastasis in all nodes, in contrast with SLNB which only provides information on 1 lymph node. With MRL metastases down to a size of 1 mm are detected. In 38% to 62% of patients with a positive sentinel lymph node (SLN), the SLN is the only positive node. ALND is performed in all these women and only afterwards judged unnecessary. We expect MRL to be able to identify women who have no (further) involvement of lymph nodes prior to SLNB or after a positive SLNB. Consequently ALND can be withheld from these women. MRL may also prove valuable in the 4% of patients where localisation of the SLN fails. Finally, because SLNB is false negative in 7-9% of patients, some patients are inadequately treated. MRL has a high sensitivity and provides information on all lymph nodes, consequently it may reduce the number of false negative SLNB findings. ;Secondary Objective: · Sensitivity on a node to node basis · Specificity, Accuracy, negative predictive value and positive predictive value on a patient to patient and node to node basis · Posttest probability negative rate · Feasibility of MRL after SLNB · Diagnostic accuracy of MRL after SLNB · Prognostic value of IMN involvement · Prognostic value of positive and negative MRL after positive SLNB followed by irradiation of the axilla · Feasibility of MRL after neoadjuvant chemotherapy · Diagnostic accuracy of MRL after neoadjuvant chemotherapy · Effect of chemotherapy on tumor positive axillary lymph nodes;Primary end point(s): The primary endpoint is the sensitivity of MRL for proved lymph node involvement by histopathology on a patient to patient basis

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026