Clinical trial · Interventional
Magnetic Resonance Imaging Using Ferumoxtran-10 in Finding Metastases to the Axillary Lymph Nodes in Patients With Breast Cancer
Phase II Study of Combidex in Axillary Node Staging in Breast Cancer
NCT00107484CI-TRIAL-00003414completedPhase 2ClinicalTrials.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)
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) using ferumoxtran-10, may help find and diagnose breast cancer that may have spread to the axillary lymph nodes and may help in planning breast cancer treatment. PURPOSE: This phase II trial is studying how well MRI using ferumoxtran-10 works in finding metastases to the axillary lymph nodes in patients with invasive breast cancer.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ferumoxtran-10 | Drug | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Changes in MR T1 and T2 signal intensity
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed invasive breast cancer * Candidate for sentinel lymph node biopsy and/or axillary lymph node dissection * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Ferritin ≤ 350 ng/mL\* * Transferrin saturation level ≤ 40%\* NOTE: \*Patients with lab values above these limits may be eligible provided there is no hemochromatosis by hematology consultation Hepatic * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal * Alkaline phosphatase normal * PT normal * Albumin normal * No history of cirrhosis Renal * Creatinine normal OR * Creatinine clearance \> 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Medically stable * No ongoing or active infection * No history of allergic reaction attributed to compounds of similar chemical or biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations) * No history of allergic reaction to any contrast media * No immunodeficiency that would predispose patient to a specific or non-specific mediator release * No contraindication to MRI, including any of the following: * Severe claustrophobia * Pacemaker * Aneurysm clips * Defibrillators * Certain types of replacement joints * Other institutional contraindication to MRI * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 30 days since prior investigational agents * More than 3 months since prior ferumoxides
References
Publications (0)
Data not yet available
No reference posted for this study.