This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    NCT02209532
Previous Study | Return to List | Next Study

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)

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Novadaq Technologies Inc.
Sponsor:
Information provided by (Responsible Party):
Novadaq Technologies Inc.
ClinicalTrials.gov Identifier:
NCT02209532
First received: July 29, 2014
Last updated: March 10, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Endometrial Cancer Uterine Cancer Cervical Cancer Device: PINPOINT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novadaq Technologies Inc.:

Primary Outcome Measures:
  • Identification of Lymph Nodes with PINPOINT [ 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 Outcome Measures:
  • Safety of Interstitial Injection of ICG, as measured by number of subjects experiencing adverse effects. [ Time Frame: Day 0 to Day 30 ]
    To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping.

  • Effectiveness of PINPOINT and Blue dye to identify lymph nodes [ 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.


Estimated Enrollment: 150
Study Start Date: December 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 > 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02209532

Contacts
Contact: Alicia Wilton 905-629-3822 ext 209 awilton@novadaq.com
Contact: Vasanthi Govindaraju, PhD 905-629-3822 ext 244 vgovindaraju@novadaq.com

Locations
United States, California
O'Connor Hospital Recruiting
San Jose, California, United States
Contact: Heather McAvoy       heather@bayareago.com   
Principal Investigator: James F. Lilja, MD         
United States, Florida
Lee Memorial Hospital Recruiting
Fort Myers, Florida, United States
Contact: Samith Sandadi, MD       Samith.Sandadi@21co.com   
Principal Investigator: Samith Sandadi, MD         
United States, New York
Memorial Sloan Kettering Recruiting
New York City, New York, United States
Contact: Marissa Mezzancello       MezzancM@mskcc.org   
Principal Investigator: Nadeem Abu-Rustum         
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States
Contact: Jessie Ehrisman       jessie.ehrisman@dm.duke.edu   
Principal Investigator: Fidel Valea, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States
Contact: Cindy Melendez       cvmelend@mdanderson.org   
Principal Investigator: Michael Frumovitz         
Canada, Ontario
Sunnybrook Health Science Centre Recruiting
Toronto, Ontario, Canada
Contact: Amanda Fonseca       amanda.fonseca@sunnybrook.ca   
Principal Investigator: Lilian Gien, MD         
Canada, Quebec
CHU de Québec - Université Laval Active, not recruiting
Quebec City, Quebec, Canada
Puerto Rico
Hospital HIMA San Pablo Recruiting
Caguas, Puerto Rico
Contact: Wilma Gonzalez       wilma.gonzalez@upr.edu   
Principal Investigator: Pedro Escobar, MD         
Sponsors and Collaborators
Novadaq Technologies Inc.
Investigators
Principal Investigator: Michael Frumovitz, MD M.D. Anderson Cancer Center
  More Information

Responsible Party: Novadaq Technologies Inc.
ClinicalTrials.gov Identifier: NCT02209532     History of Changes
Other Study ID Numbers: PP LNM 01
Study First Received: July 29, 2014
Last Updated: March 10, 2017

Keywords provided by Novadaq Technologies Inc.:
Lymph node mapping
Endometrial cancer
Uterine cancer
Cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 22, 2017