Status:
UNKNOWN
Axillary Reverse Mapping (ARM) in Breast Cancer Surgery to Prevent Lymphedema. (ARMtrial)
Lead Sponsor:
University Hospital of Ferrara
Conditions:
Breast Cancer Lymphedema
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Breast cancer related lymphedema (BCRL) is a debilitating and distressing condition affecting approximately one out of five breast cancer survivors. BCRL is a chronic swelling of the upper arm followi...
Detailed Description
The investigators will conduct a randomized clinical trial (RCT) at the S. Anna University Hospital of Ferrara (Italy) on consecutive patients undergoing SLNB for breast cancer and subsequent ALND in ...
Eligibility Criteria
Inclusion
- T1-T2 stage breast cancer
Exclusion
- axillary lymph node metastasis;
- previous surgery on the ipsilateral axilla;
- neoadjuvant chemo-radiotherapy;
- presence of primitive lymphedema of the arm;
- allergy to Iodine, thyroid disease, renal and hepatic impairment (for issues related to Indocyanine Green)
- pregnancy;
- patients refusing to participate in the study.
Key Trial Info
Start Date :
January 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03333226
Start Date
January 17 2018
End Date
December 1 2020
Last Update
January 23 2018
Active Locations (1)
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1
Azienda Ospedaliero Universitaria S. Anna
Cona, Ferrara, Italy, 44124