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Prospective randomized controlled study of Mitoxantrone hydrochloride tracer versus Methylene blue for biopsy of Sentinel lymph node in endoscopic breast cancer resection+prosthesis implantation Breast reconstruction

Prospective randomized controlled study of Mitoxantrone hydrochloride tracer versus Methylene blue for biopsy of Sentinel lymph node in endoscopic breast cancer resection+prosthesis implantation Breast reconstruction

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073181
Enrollment
Unknown
Registered
2023-07-04
Start date
2023-07-04
Completion date
Unknown
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Group A:Mitoxantrone hydrochloride tracer
Group B:Methylene blue

Sponsors

The First Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Female patients aged 18-70 (including 18 and 70 years old); (2) Preoperative pathology confirmed invasive breast cancer or ductal Carcinoma in situ; (3) Clinical T1/T2 (maximum tumor diameter = 5cm) before neoadjuvant chemotherapy; (4) Patients with clinical cN0 and cN1 before neoadjuvant chemotherapy; (5) There is no clinical or imaging basis for distant metastasis; (6) Plan to perform subcutaneous glandular resection of the nipple areola complex with preservation of the nipple; (7) BMI<40 kg/m2; (8) Patients who are allowed to undergo simultaneous endoscopic breast augmentation on the opposite breast; (9) Breast volume below average; (10) Able and willing to sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who meet any of the following exclusion criteria are excluded: Oncology: 1. Tumor mass with a diameter greater than 5cm; 2. Late tumor stage (such as cN2/cN3 or patients with inflammatory breast cancer); 3. Skin/chest wall invasion; 4. Individuals with a high risk of recurrence (based on multidisciplinary evidence) Reconstruction: 1. Age>70 years old; 2. BMI is more than 40kg/m2 (there are many other complications, such as diabetes, hypertension, and BMI alone is not a Contraindication); 3. The patient has severe illness before surgery, poor overall condition, and cannot tolerate surgery; 4. Immune dysfunction; 5. HbA1c greater than 7.5%; 6. The patient has a long-term history of smoking (2) If the patient has a history of radiotherapy after breast conserving surgery for breast cancer, pregnancy and lactation, known patients with anthraquinone allergy, patients with alcohol or sedative drug dependence, patients with mental illness, patients who have used the test drug in the past, and any patients who participated in any other clinical trial within 3 months before the study. Any breast cancer patients who plan to be pregnant during the trial or within 6 months after the study, as well as those who are participating in other clinical studies and may have an impact on participation in this trial, should also be excluded

Design outcomes

Primary

MeasureTime frame
Validity of Sentinel lymph node biopsy;

Secondary

MeasureTime frame
Time for local skin blue staining and fading;Safety indicators;

Countries

China

Contacts

Public ContactFan Linjun/ Zeng Lingjuan

The First Affiliated Hospital of the Army Medical University

zenglingjuan0213@163.com+86 180 0838 5092

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026