Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer

Summary

The aim of the study is a prospective multicentre phase-3 study that aims to evaluate the detection rate of sentinel lymph node in patients with breast cancer.

To compare the detection rates of Technetium Tc 99m Sulfur Colloid Injection(99mTc-SC) and Mitoxantrone Hydrochloride Injection for Tracing(MHI) for lymphatic tracing in patients with breast cancer.

Conditions

• Sentinel Nodes
• Breast Cancer

Interventions

DRUG

Technetium Tc 99m Sulfur Colloid Injection

Technetium \[99mTc\] Sulfur Colloid Injection (0.1-1.0 mCi; specifically 0.5 mCi for same-day surgery administered 3-6 hours prior to SLNB, or 1.0 mCi for next-day surgery administered 3-18 hours prior to SLNB) is administered via subcutaneous injection over the tumor surface (or subareolar region in cases with biopsy cavities or upper-outer quadrant tumors near the axilla). Preoperative SPECT/CT imaging is performed. Intraoperatively, a handheld gamma detector probe (GDP) is used to identify and locate "hot spot" sentinel lymph nodes (SLNs).

DRUG

Mitoxantrone Hydrochloride Injection for Tracing

Mitoxantrone Hydrochloride Injection for Tracing (0.5-2.0 mL, 5.0 mg/mL) is administered approximately 15 minutes prior to surgery via subcutaneous injection around the tumor or behind the areola for total mastectomy, or deep peritumoral subcutaneous injection for breast-conserving surgery, followed by local massage for 5-8 minutes. Intraoperatively, blue-stained lymph nodes and/or blue lymphatic channels pointing to lymph nodes are visually identified as SLNs

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Beijing Shijitan Hospital, Capital Medical University

  collaborator OTHER

• Beijing Tongren Hospital

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• HTA Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Zaoqing Fan, MD · Peking University Cancer Hospital & Institute

• Zhi Yang, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-02

Primary Completion

2025-06-03

Completion

2025-06-03

Countries

• China

Study Locations