Sentinel NodesPhase 3NCT07764653
Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer
A Phase 3 study testing Technetium Tc 99m Sulfur Colloid Injection and Mitoxantrone Hydrochloride Injection for Tracing in people with Sentinel Nodes and Breast Cancer, run by HTA Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Sentinel Nodes, Breast Cancer
- What is being tested?
- Technetium Tc 99m Sulfur Colloid Injection and Mitoxantrone Hydrochloride Injection for Tracing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2024to 3 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Conventional preoperative examination showed no clear surgical contraindications Exclusion criteria
- 1)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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial
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.
Read the detailed description
All enrolled subjects with breast cancer will receive Technetium Tc 99m Sulfur Colloid Injection and Mitoxantrone Hydrochloride Injection for Tracing sequentially, to evaluate the efficacy of the two methods for sentinel lymph node (SLN) mapping in breast cancer patients. Due to the characteristics of the investigational product and sentinel lymph node biopsy (SLNB) procedure, blinding is not feasible for this trial; therefore, an open-label design is adopted.
At least 8 subjects will be enrolled in the initial exploratory phase to investigate the lymph node uptake of 99mTc-SC, and to determine the optimal administration time, dosage, and preoperative SPECT/CT imaging schedule. These 8 subjects will not be included in the final efficacy and safety analysis set, and an additional 8 subjects will be enrolled subsequently.
- At least 4 subjects will receive no more than 0.5 mCi of Technetium Tc 99m Sulfur Colloid Injection at 6 h ± 36 min before surgery. Dynamic scintigraphy (5 min per frame, with supplementary lateral imaging of the ipsilateral side) will be performed for 60 minutes as soon as possible (2-3 min) after injection. Planar static imaging (anterior and ipsilateral lateral views) of the ipsilateral breast and axillary regions will be conducted at 2 h ± 12 min and 3 h ± 18 min, and SPECT/CT imaging (anterior view, ipsilateral lateral view, and tomographic scan) will be performed at 5 h ± 30 min, for a total of 4 scans.
- At least 4 subjects will receive no more than 1 mCi of Technetium Tc 99m Sulfur Colloid Injection at 18 h ± 120 min before surgery. Dynamic scintigraphy within 60 minutes (5 min per frame, with supplementary lateral imaging of the ipsilateral side) will be acquired as soon as possible (2-3 min) after injection. Planar static imaging (anterior and ipsilateral lateral views) of the ipsilateral breast and axillary regions will be performed at 2 h ± 12 min, 3 h ± 18 min and 6 h ± 36 min, and SPECT/CT imaging (anterior view, ipsilateral lateral view, and tomographic scan) will be conducted at 18 h ± 120 min, for a total of 5 scans.
For the remaining subjects, procedures will be implemented based on the exploratory results from the aforementioned 8 subjects:
- For subjects undergoing same-day SLNB: 0.5 mCi of 99mTc-SC will be administered; SPECT/CT imaging will be performed at 2 h ± 12 min to 5 h ± 30 min after dosing, and SLNB will be conducted at 3-6 h ± 36 min after dosing.
- For subjects undergoing next-day SLNB: 1 mCi of 99mTc-SC will be administered; SPECT/CT imaging will be performed at 3 h ± 30 min to 18 h ± 120 min after dosing, and SLNB will be completed within 18 h ± 120 min after dosing.
Technetium Tc 99m Sulfur Colloid Injection will be injected subcutaneously over the tumor surface. For subjects with an excisional biopsy cavity, or with tumors located in the upper outer quadrant close to the axilla which may interfere with imaging, subareolar injection is recommended (surgeons are advised to perform preoperative skin marking based on clinical conditions and confirm the appropriate injection site through consultation with the nuclear medicine department).
Approximately 15 minutes before surgery, all subjects will receive 0.5-2 mL (5.0 mg/mL) of Mitoxantrone Hydrochloride Injection for Tracing. For subjects undergoing total mastectomy, the injection will be administered subcutaneously around the tumor or posterior to the areola; for subjects undergoing breast-conserving surgery, the injection will be administered via two deep peritumoral subcutaneous injection points or a single point with multi-directional injection (intradermal injection and injection into the areolar area are strictly prohibited). After injection, the injection site will be massaged for 5-8 minutes, followed by sentinel lymph node biopsy.
A hand-held gamma probe will then be used to locate "hot spot" lymph nodes and mark their surface positions. An incision will be made along the skin crease over the "hot spot" lymph node, or via the total mastectomy surgical incision, to perform SLNB. Guided by the hand-held gamma probe within the incision, "hot spot" lymph nodes will be resected until no further "hot spots" are detected (radioactive count no higher than 1/10 of the maximum ex vivo SLN count). Meanwhile, blue-stained lymph nodes will be identified and removed. Subsequently, total mastectomy or breast-conserving surgery will be performed, and all blue-stained tissues will be resected as thoroughly as possible intraoperatively.
Resected lymph nodes with radioactive uptake and/or blue staining are defined as SLNs. Clinically suspicious lymph nodes that are neither "hot spots" nor blue-stained will also be resected and labeled separately.
The in vivo radioactive counts of "hot spots" and ex vivo radioactive counts of SLNs will be recorded. The following quantities will all be documented: the number of SLNs positive for both radioactive "hot spot" and blue staining, the number of SLNs positive only for radioactive "hot spot", the number positive only for blue staining, and the number of suspicious SLNs negative for both radioactive "hot spot" and blue staining.
Both intraoperative pathological diagnosis and postoperative pathological diagnosis of breast cancer SLNs are acceptable in this study. Pathological examination will be performed in accordance with the standard procedures of each investigational center, and the pathological diagnosis of each sentinel lymph node will be recorded.
- Intraoperative pathological examination: Intraoperative SLN specimens will be sectioned into 2 mm-thick frozen sections. A portion of the tissue will be used for intraoperative histopathological examination with hematoxylin and eosin (HE) staining; the remaining tissue sections will be processed for routine paraffin pathological examination after surgery, with HE staining and immunohistochemistry (IHC, if indicated). In case of discrepancy between intraoperative and postoperative pathology for an individual subject, the positive pathological result shall prevail.
- Postoperative pathological examination: All resected SLN tissues will be sampled and prepared into paraffin-embedded sections, sectioned at 2 mm thickness, and subjected to HE staining and immunohistochemistry (if indicated).
SLN metastasis will be classified according to the AJCC Cancer Staging Manual, 8th Edition. In this study, a positive SLN is defined as metastatic foci with a maximum diameter > 0.2 mm detected by histological examination or immunohistochemistry. A positive subject refers to a patient in whom at least one positive SLN is identified.
- Conditions
- Sentinel Nodes, Breast Cancer
- Being tested
- Technetium Tc 99m Sulfur Colloid Injection, Mitoxantrone Hydrochloride Injection for Tracing
- Keywords
- Technetium Tc 99m Sulfur Colloid Injection, Sentinel Nodes, Breast Cancer, Self-Controlled Clinical Trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technetium Tc 99m Sulfur Colloid InjectionDrug
Also called 99mTc-SC
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).
Mitoxantrone Hydrochloride Injection for TracingDrug
Also called MHI
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Technetium Tc 99m Sulfur Colloid Injection; Drug: Mitoxantrone Hydrochloride Injection for Tracing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel lymph node detection rate.
Measured: During surgery (Day 0 or Day 1))
Secondary outcomes (3)
The consistency between 99mTc-SC and MHI
Measured: Intraoperatively during sentinel lymph node biopsy (Day 0 or Day 1)
The coincidence between 99mTc-SC and MHI
Measured: 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.
Measured: From study drug administration through 14 days post-surgery (Day 14 ± 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start2 Jan 2024
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel NodesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- HTA Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute, Peking University People's Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing Tongren Hospital, Xuanwu Hospital, Beijing, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Renmin Hospital of Wuhan University
- Responsible party
- Sponsor
- Investigators
- Zaoqing Fan, MD, Principal investigator, Peking University Cancer Hospital & InstituteZhi Yang, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764653
- Sponsor's protocol ID
- STP-HTA202LC-001
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07764653
- Acronym / sponsor ID
- STP-HTA202LC-001
- Conditions
- Sentinel Nodes, Breast Cancer
- Keywords
- Technetium Tc 99m Sulfur Colloid Injection, Sentinel Nodes, Breast Cancer, Self-Controlled Clinical Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- HTA Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute, Peking University People's Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing Tongren Hospital, Xuanwu Hospital, Beijing, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Renmin Hospital of Wuhan University
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All enrolled subjects with breast cancer will receive Technetium Tc 99m Sulfur Colloid Injection and Mitoxantrone Hydrochloride Injection for Tracing sequentially, to evaluate the efficacy of the two methods for sentinel lymph node (SLN) mapping in breast cancer patients. Due to the characteristics of the investigational product and sentinel lymph node biopsy (SLNB) procedure, blinding is not feasible for this trial; therefore, an open-label design is adopted.
At least 8 subjects will be enrolled in the initial exploratory phase to investigate the lymph node uptake of 99mTc-SC, and to determine the optimal administration time, dosage, and preoperative SPECT/CT imaging schedule. These 8 subjects will not be included in the final efficacy and safety analysis set, and an additional 8 subjects will be enrolled subsequently.
- At least 4 subjects will receive no more than 0.5 mCi of Technetium Tc 99m Sulfur Colloid Injection at 6 h ± 36 min before surgery. Dynamic scintigraphy (5 min per frame, with supplementary lateral imaging of the ipsilateral side) will be performed for 60 minutes as soon as possible (2-3 min) after injection. Planar static imaging (anterior and ipsilateral lateral views) of the ipsilateral breast and axillary regions will be conducted at 2 h ± 12 min and 3 h ± 18 min, and SPECT/CT imaging (anterior view, ipsilateral lateral view, and tomographic scan) will be performed at 5 h ± 30 min, for a total of 4 scans.
- At least 4 subjects will receive no more than 1 mCi of Technetium Tc 99m Sulfur Colloid Injection at 18 h ± 120 min before surgery. Dynamic scintigraphy within 60 minutes (5 min per frame, with supplementary lateral imaging of the ipsilateral side) will be acquired as soon as possible (2-3 min) after injection. Planar static imaging (anterior and ipsilateral lateral views) of the ipsilateral breast and axillary regions will be performed at 2 h ± 12 min, 3 h ± 18 min and 6 h ± 36 min, and SPECT/CT imaging (anterior view, ipsilateral lateral view, and tomographic scan) will be conducted at 18 h ± 120 min, for a total of 5 scans.
For the remaining subjects, procedures will be implemented based on the exploratory results from the aforementioned 8 subjects:
- For subjects undergoing same-day SLNB: 0.5 mCi of 99mTc-SC will be administered; SPECT/CT imaging will be performed at 2 h ± 12 min to 5 h ± 30 min after dosing, and SLNB will be conducted at 3-6 h ± 36 min after dosing.
- For subjects undergoing next-day SLNB: 1 mCi of 99mTc-SC will be administered; SPECT/CT imaging will be performed at 3 h ± 30 min to 18 h ± 120 min after dosing, and SLNB will be completed within 18 h ± 120 min after dosing.
Technetium Tc 99m Sulfur Colloid Injection will be injected subcutaneously over the tumor surface. For subjects with an excisional biopsy cavity, or with tumors located in the upper outer quadrant close to the axilla which may interfere with imaging, subareolar injection is recommended (surgeons are advised to perform preoperative skin marking based on clinical conditions and confirm the appropriate injection site through consultation with the nuclear medicine department).
Approximately 15 minutes before surgery, all subjects will receive 0.5-2 mL (5.0 mg/mL) of Mitoxantrone Hydrochloride Injection for Tracing. For subjects undergoing total mastectomy, the injection will be administered subcutaneously around the tumor or posterior to the areola; for subjects undergoing breast-conserving surgery, the injection will be administered via two deep peritumoral subcutaneous injection points or a single point with multi-directional injection (intradermal injection and injection into the areolar area are strictly prohibited). After injection, the injection site will be massaged for 5-8 minutes, followed by sentinel lymph node biopsy.
A hand-held gamma probe will then be used to locate "hot spot" lymph nodes and mark their surface positions. An incision will be made along the skin crease over the "hot spot" lymph node, or via the total mastectomy surgical incision, to perform SLNB. Guided by the hand-held gamma probe within the incision, "hot spot" lymph nodes will be resected until no further "hot spots" are detected (radioactive count no higher than 1/10 of the maximum ex vivo SLN count). Meanwhile, blue-stained lymph nodes will be identified and removed. Subsequently, total mastectomy or breast-conserving surgery will be performed, and all blue-stained tissues will be resected as thoroughly as possible intraoperatively.
Resected lymph nodes with radioactive uptake and/or blue staining are defined as SLNs. Clinically suspicious lymph nodes that are neither "hot spots" nor blue-stained will also be resected and labeled separately.
The in vivo radioactive counts of "hot spots" and ex vivo radioactive counts of SLNs will be recorded. The following quantities will all be documented: the number of SLNs positive for both radioactive "hot spot" and blue staining, the number of SLNs positive only for radioactive "hot spot", the number positive only for blue staining, and the number of suspicious SLNs negative for both radioactive "hot spot" and blue staining.
Both intraoperative pathological diagnosis and postoperative pathological diagnosis of breast cancer SLNs are acceptable in this study. Pathological examination will be performed in accordance with the standard procedures of each investigational center, and the pathological diagnosis of each sentinel lymph node will be recorded.
- Intraoperative pathological examination: Intraoperative SLN specimens will be sectioned into 2 mm-thick frozen sections. A portion of the tissue will be used for intraoperative histopathological examination with hematoxylin and eosin (HE) staining; the remaining tissue sections will be processed for routine paraffin pathological examination after surgery, with HE staining and immunohistochemistry (IHC, if indicated). In case of discrepancy between intraoperative and postoperative pathology for an individual subject, the positive pathological result shall prevail.
- Postoperative pathological examination: All resected SLN tissues will be sampled and prepared into paraffin-embedded sections, sectioned at 2 mm thickness, and subjected to HE staining and immunohistochemistry (if indicated).
SLN metastasis will be classified according to the AJCC Cancer Staging Manual, 8th Edition. In this study, a positive SLN is defined as metastatic foci with a maximum diameter > 0.2 mm detected by histological examination or immunohistochemistry. A positive subject refers to a patient in whom at least one positive SLN is identified.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: 99mTc-SC and MHI Intra-individual Control Group | Experimental | Drug: Technetium Tc 99m Sulfur Colloid Injection, Drug: Mitoxantrone Hydrochloride Injection for TracingAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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；
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technetium Tc 99m Sulfur Colloid InjectionAlso: 99mTc-SCTechnetium [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 | Experimental: 99mTc-SC and MHI Intra-individual Control Group |
| Mitoxantrone Hydrochloride Injection for TracingAlso: MHIMitoxantrone 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 | Drug | Experimental: 99mTc-SC and MHI Intra-individual Control Group |
Primary outcome
Sentinel lymph node detection rate.
Time frame: During surgery (Day 0 or Day 1))
3 secondary outcomes
The consistency between 99mTc-SC and MHI
Time frame: Intraoperatively during sentinel lymph node biopsy (Day 0 or Day 1)
The coincidence between 99mTc-SC and MHI
Time frame: 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.
Time frame: From study drug administration through 14 days post-surgery (Day 14 ± 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaoqing Fan, MD principal investigator
Peking University Cancer Hospital & Institute
Zhi Yang, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Technetium Tc 99m Sulfur Colloid Injection and Mitoxantrone Hydrochloride Injection for Tracing in people with Sentinel Nodes and Breast Cancer, run by HTA Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sentinel lymph node detection rate. (time frame: During surgery (Day 0 or Day 1))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.