This is a randomized, prospective, open label, multicenter study to assess the safety and utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of lymph nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN mapping.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
O'Connor Hospital
San Jose, California, United States
Lee Memorial Hospital
Fort Myers, Florida, United States
Memorial Sloan Kettering
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
CHU de Québec - Université Laval
Québec, Quebec, Canada
Hospital HIMA San Pablo
Caguas, Puerto Rico
Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified
To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.
Time frame: Day 0
Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye
To evaluate the effectiveness of PINPOINT and Blue dye in the identification of at least one lymph node (confirmed to be lymphoid tissue) per subject.
Time frame: Day 0
Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye.
To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue).
Time frame: Day 0
Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye.
To determine the proportion of lymph nodes identified from following lymphatic channels
Time frame: Day 0
Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG
To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping, as measured by number of subjects experiencing adverse effects related to the study treatment.
Time frame: Day 0 to Day 30
Anatomic Distribution of Lymph Nodes
To determine the anatomic distribution of lymph nodes
Time frame: Day 0
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