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 (FILM)

March 4, 2019 updated by: Novadaq Technologies ULC, now a part of Stryker

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Blue - 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.
Device: PINPOINT
PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Active Comparator: PINPOINT - Blue
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.
Device: PINPOINT
PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novadaq Technologies ULC, now a part of Stryker

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP LNM 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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