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

Cervical Cancer Clinical Trial

— FILM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209532
• Other study ID #: PP LNM 01
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2019
• Source: Novadaq Technologies ULC, now a part of Stryker
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Device:
• PINPOINT
PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Locations

Country	Name	City	State
Canada	CHU de Québec - Université Laval	Quebec City	Quebec
Canada	Sunnybrook Health Science Centre	Toronto	Ontario
Puerto Rico	Hospital HIMA San Pablo	Caguas
United States	Duke Cancer Institute	Durham	North Carolina
United States	Lee Memorial Hospital	Fort Myers	Florida
United States	MD Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan Kettering	New York	New York
United States	O'Connor Hospital	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Novadaq Technologies ULC, now a part of Stryker

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Secondary	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.	Day 0
Secondary	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).	Day 0
Secondary	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	Day 0
Secondary	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.	Day 0 to Day 30
Secondary	Anatomic Distribution of Lymph Nodes	To determine the anatomic distribution of lymph nodes	Day 0