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

Breast Cancer Clinical Trial

— FILM-B  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200704
• Other study ID #: SPY LNM 01
• Status: Completed
• Phase: Phase 3
• Start date: January 4, 2019
• Est. completion date: September 28, 2020

Study information

• Verified date: August 2023
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 28, 2020
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymph Node Mapping
• Sentinel Lymph Node Biopsy

Intervention

Combination Product:
• IC2000 and SPY-PHI
Investigational treatment to assess 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 in early stage breast cancer
• Tc-99m radioactive colloid and Gamma Probe
Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer

Locations

Country	Name	City	State
Canada	Fraser Health Authority	Port Moody	British Columbia
Canada	CHU de Québec-Université Laval (Hôpital du Saint-Sacrement)	Quebec City	Quebec
United States	Inova Health System	Alexandria	Virginia
United States	Methodist Dallas Medical Center	Dallas	Texas
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	Arizona Center for Cancer Care	Scottsdale	Arizona
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe		From Technetium-99 (Tc-99m) injection to the completion of surgery
Secondary	Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe		From Technetium-99 (Tc-99m) injection to the completion of surgery
Secondary	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		From Technetium-99 (Tc-99m) injection to the completion of surgery
Secondary	To Assess the Safety of Intradermal Injection of IC2000	Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0	From Technetium-99 (Tc-99m) injection to the completion of surgery