Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer (FILM-B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200704
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Novadaq Technologies ULC, now a part of Stryker

Brief Summary:
This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures as confirmed by Technitium99m (Tc99m) and Gamma Probe.

Condition or disease Intervention/treatment Phase
Breast Cancer Lymph Node Mapping Sentinel Lymph Node Biopsy Combination Product: IC2000 and SPY-PHI Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open label, within patient study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Subjects With Breast Cancer
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IC2000/SPY-PHI
Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.
Combination Product: IC2000 and SPY-PHI
This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures as confirmed by Tc-99m and Gamma Probe.




Primary Outcome Measures :
  1. To assess the effectiveness of IC2000 and SPY-PHI (SPY Portable Handheld Imager) Fluorescence Imaging System in the identification of lymph nodes (histology confirmed lymph nodes), during lymphatic mapping [ Time Frame: During treatment period ]
    Proportion of lymph nodes identified by IC2000/SPY-PHI compared to the proportion of lymph nodes identified by Tc99m/Gamma Probe


Secondary Outcome Measures :
  1. To evaluate the effectiveness of IC2000/SPY-PHI and Tc99m/Gamma Probe in the identification of at least one lymph node (histology confirmed lymph node) per subject [ Time Frame: During treatment period ]
    Proportion of subjects that have at least one lymph node identified by IC2000/SPY-PHI, and the proportion of subjects that have at least one lymph node identified by Tc99m/Gamma Probe

  2. To evaluate the effectiveness of IC2000 and SPY-PHI as an intraoperative fluorescence visualization tool in delineation and mapping of lymphatic vessels in the identification of lymph nodes (histology confirmed lymph nodes) [ Time Frame: During treatment period ]
    Proportion of lymph nodes identified by IC2000/SPY-PHI by following a fluorescent lymphatic vessel, and the proportion of identified lymph nodes with no lymphatic vessels visible by IC2000/SPY-PHI

  3. To assess the safety of intradermal injection of IC2000 [ Time Frame: During treatment period ]
    Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be 18 years of age or older
  2. Subjects with American Cancer Society Clinical Stage 0 Ductal Carcinoma in Situ (DCIS) (Stage 0, Tis, N0, M0), IA (T1*, N0, M0), IB ((T0, N1mi, M0) or T1*, N1mi, M0)) or Stage IIA (T0, N1**M0, or T1, N1**, M0 or T2, N0, M0)1 breast cancer undergoing surgery to remove tumor draining LNs.

    Where:

    • Tis = Ductal carcinoma in situ
    • T0 = No evidence of primary tumor
    • T1 = Tumor ≤ 20 mm in greatest diameter
    • T1* = Includes T1mi
    • T2 = Tumor >20 mm but ≤ 50 mm in greatest diameter
    • N0 = No regional lymph node metastasisq1`
    • N1 = Metastasis to movable ipsilateral level I, II axillary LNs
    • N1** = T0 and T1 tumors with nodal micro-metastasis only are excluded from Stage IIA and are classified Stage IB.
    • mi = Micro-metastasis
    • M0 = Disease has not metastasized from Stage IIA and are classified Stage IB.
    • M0= No evidence of metastasis
    • mi= Micrometastasis
  3. Subjects with clinically negative nodal status (N0) with or without neoadjuvant chemotherapy
  4. Subjects with negative metastatic involvement (M0)
  5. Subjects of child-bearing potential must not be pregnant or lactating and must have a negative pregnancy test at Baseline
  6. Have signed an approved informed consent form for the study
  7. Be willing to comply with the protocol

Exclusion Criteria:

  1. Have had prior axillary surgery or ipsilateral radiation in the breast(s) that is planned for the procedure
  2. Advanced breast cancer subjects with stage IIB, III and IV
  3. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
  4. Subjects who have participated in another investigational study within 30 days prior to surgery
  5. Pregnant or lactating subject
  6. Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200704


Contacts
Layout table for location contacts
Contact: Alicia Wilton 416-949-4992 alicia.wilton@stryker.com
Contact: Matt McKittrick 610-674-5544 matthew.mckittrick@stryker.com

Locations
Layout table for location information
United States, Arizona
Arizona Center for Cancer Care Active, not recruiting
Scottsdale, Arizona, United States, 85258
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Amber Saleem    202-444-3202    as4295@georgetown.edu   
Principal Investigator: Eleni Tousimis, MD         
United States, Florida
Baptist MD Anderson Cancer Center Recruiting
Jacksonville, Florida, United States, 32207
Contact: Dana Kontras    904-202-7070      
Principal Investigator: Beth-Ann Lesnikoski, MD         
Sub-Investigator: Laila Samiian, MD         
United States, Texas
Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
Contact: Melba Townsend    214-947-4463    melbatownsend@mhd.com   
Principal Investigator: Allison DiPasquale, MD         
United States, Virginia
Inova Health System Recruiting
Alexandria, Virginia, United States, 22306
Contact: Percy Julian    703-776-3505      
Principal Investigator: David Weintritt, MD         
Canada, British Columbia
Fraser Health Authority Recruiting
Port Moody, British Columbia, Canada, V3H 3W9
Contact: Gillian Foster    604-461-2022 ext 548203      
Principal Investigator: Michelle Goecke, MD         
Canada, Quebec
CHU de Québec-Université Laval (Hôpital du Saint-Sacrement) Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Contact: Fanie Bourgault    418-525-4444 ext 82697    fanie.bourgault@crchudequebec.ulaval.ca   
Principal Investigator: Christine Desbiens, MD         
Sub-Investigator: Dominique Boudreau, MD         
Sub-Investigator: Dominique Leblanc, MD         
Sponsors and Collaborators
Novadaq Technologies ULC, now a part of Stryker
Investigators
Layout table for investigator information
Principal Investigator: David Weintritt, MD, FACS National Breast Center
Layout table for additonal information
Responsible Party: Novadaq Technologies ULC, now a part of Stryker
ClinicalTrials.gov Identifier: NCT03200704    
Other Study ID Numbers: SPY LNM 01
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases