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

NCT07764653 | Completed Phase 3

• 1 other identifier: STP-HTA202LC-001
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Technetium Tc 99m Sulfur Colloid Injection; Sentinel Nodes; Breast Cancer; Self-Controlled Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Sentinel lymph node detection rate.

  During surgery (Day 0 or Day 1))

Secondary Outcomes (3)

• The consistency between 99mTc-SC and MHI

  Intraoperatively during sentinel lymph node biopsy (Day 0 or Day 1)

• The coincidence between 99mTc-SC and MHI

  Up to 14 days post-surgery (Day 14 ± 3)

• Observe the incidence and severity of adverse events ( AE ) and severe adverse events ( SAE ), as well as abnormal laboratory test indicators.

  From study drug administration through 14 days post-surgery (Day 14 ± 3)

Other Outcomes (2)

• Explore the effect of pretreatment time before 99mTc-SC on the detection rate

  Intraoperatively during sentinel lymph node biopsy (Day 0 or Day 1)

• Explore the rationality of the positive threshold of hand-held gamma probe for sentinel lymph node radioactive counts.

  Up to 14 days post-surgery (Day 14 ± 3)

Study Arms (1)

Experimental: 99mTc-SC and MHI Intra-individual Control Group

EXPERIMENTAL

All enrolled patients will receive both Technetium \[99mTc\] Sulfur Colloid Injection (99mTc-SC) and Mitoxantrone Hydrochloride Injection for Tracer (MHI) as intra-individual controls prior to sentinel lymph node biopsy (SLNB). 1. 99mTc-SC Administration: Administered subcutaneously (peritumoral or subareolar) 3 to 18 hours prior to surgery. The dosage is scheduled based on surgery timing: Same-day SLNB: 0.5 mCi 99mTc-SC injected 3 to 6 hours (±36 min) before SLNB. Next-day SLNB: 1.0 mCi 99mTc-SC injected 3 to 18 hours (±120 min) before SLNB. 2. MHI Administration: 0.5 to 2.0 mL (5.0 mg/mL) of MHI is injected subcutaneously (peritumoral or deep subcutaneous) approximately 15 minutes before SLNB, followed by local massage for 5 to 8 minutes. Sentinel lymph nodes (SLNs) will be localized and identified intraoperatively using a handheld gamma detector probe (hot spots) and visual inspection for blue staining.

Drug: Technetium Tc 99m Sulfur Colloid Injection; Drug: Mitoxantrone Hydrochloride Injection for Tracing

Interventions

Technetium Tc 99m Sulfur Colloid Injection DRUG

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).

Also known as: 99mTc-SC

Experimental: 99mTc-SC and MHI Intra-individual Control Group

Mitoxantrone Hydrochloride Injection for Tracing DRUG

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

Also known as: MHI

Experimental: 99mTc-SC and MHI Intra-individual Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and voluntarily sign a written informed consent.
• Female subjects aged 18-70 years ( including 18 and 70 years ).
• Histologically confirmed diagnosis of invasive breast cancer or primary invasive breast cancer or ductal carcinoma in situ (DCIS) ；
• Clinical stage 1 or 2；
• For subjects undergoing surgical treatment, axillary sentinel lymph node biopsy is part of the surgical plan；
• The axillary lymph nodes were negative by imaging examination or confirmed by fine needle aspiration.

You may not qualify if:

• )Participants are allergic to the test drug or its excipients or have a history of severe drug allergy ; 2)Participants with prior surgery for breast cancer or neoadjuvant chemotherapy ; 3)inflammatory breast cancer ; 4)Ipsilateral axillary clinical examination or imaging examination positive or puncture lymph node pathology positive, no breast cancer histopathological diagnosis or no puncture pathological examination ; 5)Have received any form of breast augmentation surgery ; 6)Participants with liver or kidney dysfunction, ALT, AST\>2.5 times ULN, Bilirubin \>1.5 times ULN, Serum creatinine \>1.5 times, or Investigators believe that liver and / or kidney damage to the extent that patients should not participate in this study;； 7)With serious or uncontrollable diseases : such as severe cardiovascular and cerebrovascular diseases ( blood disease, chronic congestive heart failure NYHA classification ≥ III level, etc. ), severe pulmonary insufficiency ( one second rate FEV1 / FVC \< 50 % or FEV1 \< 50 % predicted value or maximum ventilation volume per minute MVV \< 50L / min ), psychiatric patients ; 8)Participants with active infection of infectious diseases screening ( hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody ) ; 9)participated in clinical trials of other drugs within 3 months before screening; 10)) Patients with positive pregnancy test or pregnancy plan during lactation or screening period to 3 months after administration and unwilling to take effective contraceptive measures or egg donation plan; 11)Investigators considered that it was not suitable for the patients to participate in this trial

Sponsors & Collaborators

• HTA Co., Ltd.: lead
• Peking University Cancer Hospital & Institute: collaborator
• Peking University People's Hospital: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Beijing Tongren Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Tongji Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Renmin Hospital of Wuhan University: collaborator

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Technetium Tc 99m Sulfur Colloid; Mitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfur Compounds; Inorganic Chemicals; Technetium Compounds; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds

Study Officials

• Zaoqing Fan, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Zhi Yang, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 14, 2026
• Study Start: January 2, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

CN (1)