Clinical trial · Interventional
Gadofosveset for Axillary Staging in Breast Cancer Patients
Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study
NCT01437865CI-TRIAL-00006678completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared to current nodal staging methods. The accuracy of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the SNLB or ALND will be regarded as the golden standard for nodal involvement.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gadofosveset contrast agent enhanced MRI Axilla | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gadofosveset enhanced MRI Axilla
- interventionNames
- Drug: Gadofosveset contrast agent enhanced MRI Axilla
Primary outcomes (1)
- measure
- The accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases
- timeFrame
- Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.
- description
- The main study parameter will be the accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRI as 0= benign, 1=malign. These results will be compared with the histopathological results of the SNLB procedure of ALND procedure on an node by node basis. So the accuray can be calculated.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging. 2. Tumor must be a T2 according the TNM 6-classification. 3. The ultrasound of the axilla must be suspect for nodal metastases. 4. Willing and able to undergo all study procedures 5. Has personally provided written informed consent. Exclusion Criteria: 1. Age \<18 2. History of prior chemotherapy 3. History of prior radiotherapy of the surrounding areas of the axilla. 4. Pregnancy 5. Contra indications for MRI such as pacemaker, aneurysm clips or severe claustrophobia. 6. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®) 7. Being unable to give informed consent in person 8. Acute or chronic severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m2). 9. Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
References
Publications (0)
Data not yet available
No reference posted for this study.