Fluorescein for Sentinel Lymph Node Biopsy (SLNB) in Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01614184|
Recruitment Status : Withdrawn
First Posted : June 7, 2012
Last Update Posted : July 10, 2013
University of Utah
Information provided by (Responsible Party):
University of Utah
The study goal is to develop a new method of intraoperative lymphatic mapping with fluorescent contrast agents to improve the outcome of therapeutic breast cancer surgery.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Fluorescein||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fluorescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Operable Breast Cancer|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: All patients
All patients enrolled in study.
Fluorescite® (fluorescein injection, USP) 10% fluorescein sodium diluted to from 1% to 0.001% in sterile saline, 0.25 ml injected intradermally peri-tumoral or peri-areolar. A single dose regimen.
Other Name: Fluorescite®
Primary Outcome Measures :
- Sentinel Lymph node (SLN) detection [ Time Frame: 36 months ]Ability of peri-areolar or peri-tumoral fluorescein to detect SLNs in patients with operable breast cancer.
Secondary Outcome Measures :
- Fluorescence detection [ Time Frame: 36 months ]To evaluate the ability to detect fluorescein fluorescence transdermally with a fluorometer.
- Correlation between two radiation intensities [ Time Frame: 36 months ]To evaluate if there is a correlation between SLN ex-vivo fluorescent intensity and SLN ex-vivo gamma radiation intensity.
- Correlation between intensity and metastasis [ Time Frame: 36 months ]To evaluate if there is a correlation between SLN ex-vivo fluorescent intensity and SLN metastasis.
- Fluorescence detection after processing [ Time Frame: 36 months ]To evaluate if fluorescein fluorescence can be detected in the SLN after fixation and histological processing.
- Number of patients with adverse events [ Time Frame: 36 months ]To evaluate the safety of peri-areolar or peri-tumoral fluorescein injections.
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