Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer

Completed · Early Phase 1

Conditions studied: Breast Cancer

In brief

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 imaging.

Key facts

Study ID

NCT01468649

Run by

Beth Israel Deaconess Medical Center

People needed

50

Starts

2011-06-01

Expected to finish

2013-12-01

Last updated by the study team

2017-03-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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