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)

Novadaq Technologies

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Lymph Node Mapping; Sentinel Lymph Node Biopsy

Treatments: Combination Product: Tc-99m radioactive colloid and Gamma Probe; Combination Product: IC2000 and SPY-PHI

Study type: Interventional

Funder types: Industry

Identifiers

NCT03200704

SPY LNM 01

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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152 participants in 1 patient group

IC2000/SPY-PHI

Experimental group

Description:

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.

Treatment:

Combination Product: Tc-99m radioactive colloid and Gamma Probe

Combination Product: IC2000 and SPY-PHI