An observational study in Breast Cancers, Mastectomy and Breast Reconstruction and Skin Necrosis, sponsored by University Medical Center Groningen. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by University Medical Center Groningen · Observational
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 50 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
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All patients undergoing mastectomy with immediate reconstruction using ICG-NIR (as standard care) will be included if they meet the inclusion criteria. The treating surgeon will screen the patients and ask for their consent to use their data.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients (those undergoing mastectomy with immediate breast reconstruction) belong to the same cohort.
Correlation between occurrence of postoperative skin necrosis and quantified perfusion parameters
The occurrence of postoperative skin necrosis, defined as clinically evident necrosis of the mastectomy skin flap or subcutaneous fat, within the postoperative period. This will be correlated with quantified perfusion parameters obtained from intraoperative ICG-NIR fluorescence angiography, with the aim of determining the predictive value of these parameters.
Time frame: From enrollment to the end of analysis at 1 year and a half
Diagnostic accuracy
Diagnostic accuracy of ICG-NIR fluorescence angiography in predicting postoperative skin necrosis, assessed by: Sensitivity Specificity Positive and negative predictive values Area under the receiver operating characteristic (ROC) curve (AUC)
Time frame: From enrollment to the end of analysis at 1 year and a half
Optimal cut-off values
Determination of optimal cut-off values for key ICG-NIR perfusion parameters (e.g., maximum fluorescence intensity, slope, time-to-peak, perfusion index), using ROC analysis, to differentiate between adequately and inadequately perfused tissue. The optimal cut-off values for perfusion parameters will be identified using Youden's index.
Time frame: From enrollment to the end of analysis at 1 year and a half
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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