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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)

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ClinicalTrials.gov Identifier: NCT02209532
Recruitment Status : Completed
First Posted : August 6, 2014
Results First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Novadaq Technologies ULC, now a part of Stryker

Tracking Information
First Submitted Date  ICMJE July 29, 2014
First Posted Date  ICMJE August 6, 2014
Results First Submitted Date  ICMJE November 19, 2018
Results First Posted Date  ICMJE March 25, 2019
Last Update Posted Date March 25, 2019
Study Start Date  ICMJE December 2015
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2014)
Identification of Sentinel Lymph Nodes with PINPOINT [ Time Frame: Day 0 ]
Intra-operative PINPOINT in identification of lymph nodes in patients with uterine and cervical malignancies who are undergoing lymph node mapping.
Change History Complete list of historical versions of study NCT02209532 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • 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.
  • 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).
  • 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
  • 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.
  • Anatomic Distribution of Lymph Nodes [ Time Frame: Day 0 ]
    To determine the anatomic distribution of lymph nodes
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2014)
Safety of Interstitial Injection of ICG, as measured by number of patients experiencing adverse effects. [ Time Frame: Day 0 to Day 30 ]
To demonstrate that interstitial injection of ICG for intra-operative PINPOINT Near Infrared Fluorescence Imaging does not cause side effects. The ICG will be injected into the cervix, and the cervix will be removed as part of the hysterectomy. Therefore, side effects will be measured by number of patients who experience allergic reaction.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrial Cancer
  • Uterine Cancer
  • Cervical Cancer
Intervention  ICMJE Device: PINPOINT
PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Study Arms  ICMJE
  • 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.
    Intervention: Device: PINPOINT
  • 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.
    Intervention: Device: PINPOINT
Publications * Frumovitz M, Plante M, Lee PS, Sandadi S, Lilja JF, Escobar PF, Gien LT, Urbauer DL, Abu-Rustum NR. Near-infrared fluorescence for detection of sentinel lymph nodes in women with cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, non-inferiority trial. Lancet Oncol. 2018 Oct;19(10):1394-1403. doi: 10.1016/S1470-2045(18)30448-0. Epub 2018 Aug 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2017)
180
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2014)
150
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02209532
Other Study ID Numbers  ICMJE PP LNM 01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novadaq Technologies ULC, now a part of Stryker
Study Sponsor  ICMJE Novadaq Technologies ULC, now a part of Stryker
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Frumovitz, MD M.D. Anderson Cancer Center
PRS Account Novadaq Technologies ULC, now a part of Stryker
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP