Clinical trial NCT01468649: Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer
Official title: Phase II Real-Time NIR-Guided Sentinel Lymph Node Mapping in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: Breast Cancer
Sentinel Lymph Node Mapping
Intraoperative Imaging
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Dana-Farber Cancer Institute
First posted: 2011-11-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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 imaging.

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 breast cancer SLN mapping with Tc-99m will be enrolled in this study.

Prior to surgery, patients will undergo lymphoscintigraphy as is standard of care. At the time of SLN mapping, the patient will be injected with indocyanine green dye (ICG). Concurrently, a custom-designed imaging platform that utilizes NIR fluorescence optics will be employed to identify the dye and its path through the lymphatic track, and its eventual highlighting of the SLN. Both color images and NIR images will be merged to give the operating surgeon a clear picture of the ICG track superimposed over anatomical landmarks. This technique will identify the SLN and provide an accurate video image of its location. The surgeon will resect all SLNs identified by Tc-99m or NIR fluorescence, and then confirm the radioactivity and NIR fluorescence signal in each after resection.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Sensitivity of Real-Time Intraoperative NIR Mapping
timeFrame: One Day (day 1)
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: One Day (day 1)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: John V. Frangioni, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: