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Clinical study for methylene blue fluorescence imaging applied in breast cancer surgey

Clinical study for real-time breast cancer detection by using near-infrared fluorescence imaging navigation system and methylene blue

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900020801
Enrollment
Unknown
Registered
2019-01-19
Start date
2019-01-12
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

breast cancer

Interventions

Sponsors

Institute of Automation, Chinese Academy of Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. patients undergoing breast surgery; 2. normal liver and kidney function before surgery; 3. no iodine and contrast agent allergy history, and methylene blue skin test negative; 4. score of general physical condition ECOG: 0-2; No major organ dysfunction; 5. voluntarily participate in the study and sign the informed consent; 6. Aged 18 to 70 years old.

Exclusion criteria

Exclusion criteria: 1. preoperative renal dysfunction and other organ abnormalities (methylene blue is mainly excreted by the kidney); 2. history of iodine or other contrast agent allergy, or methylene blue skin test positive; 3. diabetic patients; 4. pregnant or lactating patients; 5. Consolidate other uncontrolled co-morbidities.

Design outcomes

Primary

MeasureTime frame
Breast cancer detection rate;Positive margin rate;Survival rate;Adverse reaction rate;

Countries

China

Contacts

Public ContactKun Wang

Institute of Automation, Chinese Academy of Sciences

kun.wang@ia.ac.cn+86 18612965656

Outcome results

None listed

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