Status:
NOT_YET_RECRUITING
Prediction of ICG for Skin Necrosis in Mastectomy With Immediate Reconstruction
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Martini Hospital Groningen
Conditions:
Breast Cancers
Mastectomy and Breast Reconstruction
Eligibility:
FEMALE
18+ years
Brief Summary
Background Breast cancer represents 30 percent of newly diagnosed malignancies in female patients and is the leading cause of death in middle-aged women. Surgical treatment of breast cancer is perform...
Eligibility Criteria
Inclusion
- Age \>18 years
- Patients undergoing mastectomy with immediate reconstruction using ICG-NIR
- Patients are mentally competent
- Written informed consent
Exclusion
- Patients with known allergy to ICG or iodinated contrast media
- Pregnant or lactating women
- Patients with dialysis-dependent renal failure and renal transplantation
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06956443
Start Date
June 1 2025
End Date
December 1 2026
Last Update
May 4 2025
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