Status:
COMPLETED
Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The objective of this Phase II study is to assess the diagnostic accuracy of sentinel lymph node (SLN) identification in patients with breast cancer using near-infrared (NIR) fluorescence optical imag...
Detailed Description
Fifty participants consented from Brigham and Women's Hospital (currently enrolling) and Beth Israel Deaconess Medical Center (currently non-enrolling), who will be undergoing standard of care for bre...
Eligibility Criteria
Inclusion
- Participant must have histologically confirmed breast cancer and be deemed an appropriate surgical candidate with consent for a sentinel lymph node mapping by their oncologic surgeon.
- Age minimum: 18 years.
- Participant must be receiving a planned lymphoscintigraphy procedure.
- Participant must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Participants who choose not to proceed with sentinel lymph node biopsy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy.
- Women who are pregnant or may become pregnant, as well as those women who are breastfeeding, will be excluded from this study.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01468649
Start Date
June 1 2011
End Date
December 1 2013
Last Update
March 7 2017
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215