Prediction of ICG for Skin Necrosis in Mastectomy With Immediate Reconstruction

NCT ID: NCT06956443

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-01

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 performed with breast-conserving surgery or mastectomy. An increasing proportion of breast cancer patients undergo breast reconstruction after mastectomy. Reconstruction can be performed using various techniques that may involve the use of autologous tissues, implants, or a combination of both. However, mastectomy followed by immediate reconstruction can be associated with complications, including skin and fat necrosis, which occurs in 20% of cases.

When assessing tissue perfusion during immediate reconstruction, the surgeon relies on subjective observations, including skin color, capillary refill, and the occurrence of bleeding. One possible technique to assist the surgeon in assessing tissue perfusion is near-infrared (NIR) fluorescence imaging with Indocyanine Green (ICG). ICG can visualize tissue perfusion, because once in the bloodstream it is completely and permanently fixed to plasma proteins and circulates only in the intravascular compartment. ICG was approved for clinical use of tissue perfusion as early as 1956, such as in intestinal anastomoses, for the perfusion of free flaps or parathyroid glands.

ICG can also help predict postoperative skin necrosis in breast reconstruction after mastectomy. In patients undergoing (reconstructive) breast surgery, the intraoperative use of ICG NIR fluorescence imaging has been shown to help surgeons assess skin viability, thereby reducing the occurrence of skin necrosis in several studies. This reduction in necrosis can be explained by the intraoperative removal of tissue with reduced fluorescence intensity, observed with ICG NIR fluorescence imaging. However, there is no consensus on which ICG-NIR perfusion parameter is most accurate for assessing tissue perfusion. Further research is needed to determine cut-off values for adequate tissue perfusion. This study focuses on quantifying perfusion parameters and determining the diagnostic accuracy of ICG-NIR in patients undergoing mastectomy with immediate reconstruction.

What is the purpose of the study/research question? The purpose of this study is to determine the predictive value of quantified ICG fluorescence angiography for the occurrence of skin necrosis in patients undergoing mastectomy with immediate reconstruction with associated cut-off values.

Study design/procedure and intervention:

This will be a prospective cohort study of patients undergoing mastectomy with immediate reconstruction using ICG-NIR (the use of ICG during these operations is not an additional procedure).

This study will include patients who have undergone surgery with ICG (mastectomy with immediate reconstruction). We will use the videos of the ICG angiography for quantitative analysis of the data. This data will be correlated with the postoperative outcome (occurrence of skin/fat necrosis).

All patients will be asked in advance for permission to use their data. This will be processed pseudo-anonymously.

Conditions

Breast Cancers; Mastectomy and Breast Reconstruction; Skin Necrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ICG group

All patients (those undergoing mastectomy with immediate breast reconstruction) belong to the same cohort.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age >18 years

2. Patients undergoing mastectomy with immediate reconstruction using ICG-NIR

3. Patients are mentally competent

4. Written informed consent

Exclusion Criteria

1. Patients with known allergy to ICG or iodinated contrast media

2. Pregnant or lactating women

3. Patients with dialysis-dependent renal failure and renal transplantation

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Martini Hospital Groningen

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

nr. 2025-015

Identifier Type: -

Identifier Source: org_study_id