Clinical trial · Interventional
Nodal Staging in Breast Cancer With MRL
Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Manufacturer recently halted production of gadofosveset.
Summary
Brief summary (as posted)
The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL). The diagnostic performance 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 sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (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 enhanced MRL of axillary lymph nodes | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gadofosveset MRL
- interventionNames
- Drug: Gadofosveset enhanced MRL of axillary lymph nodes
Primary outcomes (1)
- measure
- The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL 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 diagnostic performace (sensitivity, specificity, NPV and PPV) of the axillary MRL in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRL 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 diagnostic performace can be calculated.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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. Exclusion Criteria: 1. Age \<18, 2. Pregnancy 3. Contra indications for MRL such as pacemaker, aneurysm clips or severe claustrophobia. 4. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®) 5. Being unable to give informed consent in person 6. Acute or chronic severe renal insufficiency (glomerular filtration rate \<45 mL/min/1.73m2)1. 7. Acute renal insufficiency of any severity due to the hepato-renal syndrome. 8. Known (or suspicion of) QT- prolongation
References
Publications (0)
Data not yet available