A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

18 years of age or older
Subjects with FIGO Clinical Stage I endometrial cancer undergoing minimally invasive hysterectomy with lymph node mapping.
Subjects with FIGO Clinical Stage IA cervical cancer ≤ 2 cm in size undergoing minimally invasive hysterectomy, trachelectomy, or conization with lymph node mapping. Subjects with clinical Stage IA1 cervical cancer without lympho vascular space involvement (LVSI) and negative margins on cone biopsy are not to be included.
Subjects with negative nodal status (N0)
Subjects with negative metastatic involvement (M0).

Exclusion Criteria

Have had prior dissection and/or radiation in pelvis.
Advanced cervical or endometrial cancer, T3/T4 lesions
Diagnosis of cervical cancer with a tumor size greater than 2 cm.
Locally advanced or inflammatory cervical or uterine cancer
Metastatic cervical or uterine cancer.
Known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
Known allergy or history of adverse reaction to Blue dye (Isosulfan blue) or triphenylmethane.
Hepatic dysfunction defined as MELD Score > 12.
Renal dysfunction defined as serum creatinine ≥ 2.0 mg/dl.
Subjects who have participated in another investigational study within 30 days prior to surgery.
Pregnant or lactating subjects.
Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.

Arm && Interventions

Group	Intervention	Description
PINPOINT - Blue	PINPOINT	The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
Blue - PINPOINT	PINPOINT	The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

Primary Outcome Measures

Name	Time	Method
Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified	Day 0	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.

Secondary Outcome Measures

Name	Time	Method
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	Day 0	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.
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.	Day 0	To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue).
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.	Day 0	To determine the proportion of lymph nodes identified from following lymphatic channels
Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG	Day 0 to Day 30	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.
Anatomic Distribution of Lymph Nodes	Day 0	To determine the anatomic distribution of lymph nodes

Locations (8): MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
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
Sunnybrook Health Science Centre
🇨🇦
Toronto, Ontario, Canada
Hospital HIMA San Pablo
🇵🇷
Caguas, Puerto Rico
CHU de Québec - Université Laval
🇨🇦
Quebec City, Quebec, Canada