Status:
UNKNOWN
Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast Cancer Patients After Neoadjuvant Treatment.
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Sysmex España S.L.
Conditions:
Breast Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the detection rate and the false negative rate of sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to radioisotope and co...
Detailed Description
Identification of Sentinel node: * Arm 1 (Tc+blue dye): Identification of SLN using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and vital blue dye before surgery. * Arm...
Eligibility Criteria
Inclusion
- Histologically proven primary invasive breast cancer with clinical stage T1 through T3, N1 through N2, M0 according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, seventh edition
- Completed or were planning to undergo neoadjuvant chemotherapy
- Prechemotherapy axillary nodal disease confirmed by fine-needle aspiration or core-needle biopsy
- The axilla is clinically and radiologically (by ultrasound) negative (ycN0) postchemotherapy and before surgery
- Removal of at least two SLNs
- Signed informed consent from each patient before study entry
Exclusion
- T4 tumors, cN3 or cM1
- The axilla is clinically and radiologically (by ultrasound) positive (ycN1) postchemotherapy
- Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to vital blue dye or radioactive product.
- Chronic iron overload
- Pacemaker or other metallic implantable device in the chest wall
- Failure to submit to medical study for geographical, social or psychological
- Patient deprived of liberty or under guardianship
- Pregnant or lactating
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02249208
Start Date
April 1 2014
End Date
June 1 2016
Last Update
September 30 2014
Active Locations (1)
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1
Hospital Universitario Vall D Hebron.
Barcelona, Spain, 08035