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Indocyanine green fluorescence (ICG) vs. 99mTechnetium (99mTc) for sentinel lymph node biopsy (SLNB) in breast cancer (BC): a single center, prospective, controlled, non-inferiority trial

Indocyanine green fluorescence (ICG) vs. 99mTechnetium (99mTc) for sentinel lymph node biopsy (SLNB) in breast cancer (BC): a single center, prospective, controlled, non-inferiority trial

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034715
Enrollment
Unknown
Registered
2020-07-16
Start date
2020-07-14
Completion date
Unknown
Last updated
2020-07-20

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

Conditions

breast cancer

Interventions

Gold Standard:99m Technetium (99mTc)
(ICG)&#32

Sponsors

Guilin Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with breast cancer diagnosed by pathology before operation; 2. Patients with informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with distant metastasis; 2. Patients with positive axillary lymph node biopsy; 3. Patients who are allergic to tracer and iodine; 4. The patients who had undergone axillary surgery before operation; 5. Patients with inflammatory breast cancer; 6. The efficacy and safety of patients were not judged according to the data.

Design outcomes

Primary

MeasureTime frame
Sentinel node detection rate;

Secondary

MeasureTime frame
Sentinel lymph node false positive rate;False negative rate of sentinel lymph node;positive predictive value of sentinel lymph node;nodal detection rate of sentinel lymph node;discordance rate between techniques;retrieval rates per subject overall and for each method;average procedure duration for each method;

Countries

Germany

Contacts

Public ContactProf. Dr. Med. Rudy Leon De Wilde

University Hospital for Gynecology, Pius Hospital, University Medicine Oldenburg, Carl von Ossietzky University Oldenburg

rudy-leon.dewilde@pius-hospital.de+49 04412291500

Outcome results

None listed

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