Clinical trial NCT03200704: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lymph Node Mapping
Sentinel Lymph Node Biopsy
Lead sponsor: Novadaq Technologies ULC, now a part of Stryker
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, open label, within patient study
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe
timeFrame: From Technetium-99 (Tc-99m) injection to the completion of surgery
Secondary outcomes:
measure: 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
timeFrame: From Technetium-99 (Tc-99m) injection to the completion of surgery
measure: 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
timeFrame: From Technetium-99 (Tc-99m) injection to the completion of surgery
measure: To Assess the Safety of Intradermal Injection of IC2000
timeFrame: From Technetium-99 (Tc-99m) injection to the completion of surgery
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Center for Cancer Care
state: Arizona
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Alexandria
country: United States
facility: Inova Health System
state: Virginia
city: Port Moody
country: Canada
facility: Fraser Health Authority
state: British Columbia
city: Quebec City
country: Canada
facility: CHU de Québec-Université Laval (Hôpital du Saint-Sacrement)
state: Quebec
Study officials:
affiliation: National Breast Center
name: David Weintritt, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: