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A single-arm study to evaluate the efficiency about using carbon nanoparticles to track nonpalpable breast cancer before neoadjuvant chemotherapy followed by breast-conserving surgery.

The efficiency about using carbon nanoparticles to track nonpalpable breast cancer before neoadjuvant chemotherapy followed by breast-conserving surgery.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-15006844
Enrollment
Unknown
Registered
2015-07-30
Start date
2015-07-13
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Breast Cancer

Interventions

Nano carbonparticles treatment group:Before the new adjuvant chemotherapy, 0.1ml carbon nanoparticles suspension was injected under ultrasound guidance at 12 points along 6 tracks which were separated

Sponsors

Department of general surgery, Fuzhou General Hospital of Nanjing Military
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female aged 18-70 years; 2. Breast cancer patients of clinical stage range I-II without surgery ,who were confirmed as infiltrating breast cancer with biopsy pathology and operative before chemotherapy; 3. The maximum lesion diameter before or after neoadjuvant therapy is less than 3cm; 4. Tumor edge to nipple >=2cm; 5. No apparant internal or oblique nipple before surgery; 6. No apparant swollen or confertus axillary lymph nodes, no metastasis in supplementary examinations; 7. Non pregnant and lactating breast cancer; 8. Heart, lung, liver and kidney shoud no obvious abnormalities, no coagulation dysfunction and other operation contraindication; 9. No other malignancy; 10. Agree to receive standard TAC regimen for 3 cycles after definite diagnosis; 11. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Multi-center lesions or malignant calcification foci; 2. The maximum lesion diameter after neoadjuvant therapy is over 3cm; 3. Internal or oblique nipple; 4. Apparant swollen or confertus axillary lymph nodes; 5. The founding of metastasis in supplementary examinations; 6. Breast cancer during pregnancy; 7. Patients who are not convenient to go to the doctors' office for recheck for any reason; 8. Complicated serious disease (such as: heart exclus disease, liver disease, kidney disease, etc) for exsist less than 2 years by estimate; 9. Have a particular allergy to Carbon nanoparticles; 10. Quit the test because of their own reasons.

Design outcomes

Primary

MeasureTime frame
Molybdenum target;Magnetic Resonance Imaging;Carcinoembryonic antigen (CEA);Carbohydrate antigen 15–3 (CA 15–3 );Negative margin;The stained number of lymph nodes and matastasis rate;The non-stained number of lymph nodes and matastasis rate;Operation duration;Postoperative cosmetic satisfaction rate;Bone Emission Computed Tomography;

Secondary

MeasureTime frame
Intraoperative bleeding volume;Computed Tomography of lung;

Countries

China

Contacts

Public ContactYu Wang
flyfishwang@hotmail.com+86 13805019453

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026