A Randomized, Prospective, Open Label, Multicenter 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

Novadaq Technologies ULC, now a part of Stryker8 sites in 3 countries180 target enrollmentDecember 2015

ConditionsEndometrial Cancer Uterine Cancer Cervical Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Endometrial Cancer
Sponsor: Novadaq Technologies ULC, now a part of Stryker
Enrollment: 180
Locations: 8
Primary Endpoint: Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

June 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Novadaq Technologies ULC, now a part of Stryker

Responsible Party

Sponsor

Eligibility Criteria

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 \>
•Renal dysfunction defined as serum creatinine ≥ 2.0 mg/dl.
•Subjects who have participated in another investigational study within 30 days prior to surgery.

Outcomes

Primary Outcomes

Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified

Time Frame: 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 Outcomes

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)
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)
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)
Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG(Day 0 to Day 30)
Anatomic Distribution of Lymph Nodes(Day 0)