Fluorescein for Sentinel Lymph Node Biopsy (SLNB) in Breast Cancer
This study has been withdrawn prior to enrollment.
University of Utah
Information provided by (Responsible Party):
University of Utah
First received: March 6, 2012
Last updated: July 8, 2013
Last verified: July 2013
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Fluorescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Operable Breast Cancer|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by University of Utah:
Primary Outcome Measures:
- Sentinel Lymph node (SLN) detection [ Time Frame: 36 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]To evaluate the ability to detect fluorescein fluorescence transdermally with a fluorometer.
- Correlation between two radiation intensities [ Time Frame: 36 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]To evaluate if there is a correlation between SLN ex-vivo fluorescent intensity and SLN metastasis.
- Fluorescence detection after processing [ Time Frame: 36 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]To evaluate the safety of peri-areolar or peri-tumoral fluorescein injections.
|Study Start Date:||May 2008|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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®
Contacts and Locations
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