Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked about using a different method to find these lymph nodes using a special dye called Indocyanine Green (ICG). This method involves shining a special camera on the skin. So far, no studies have directly compared the ICG method to the standard blue dye. The ICG camera could make things easier for patients and doctors, and more patients might choose to have their lymph nodes checked with this new method. The goal of our study is to see if using the ICG dye is just as good as the standard method of blue dye.
Study Type
OBSERVATIONAL
Enrollment
10
Indocyanine green (ICG) is a fluorescent dye that has been used for the imaging of cancers in the body for more than 30 years.
Tufts Medical Center
Boston, Massachusetts, United States
Detection Rate of SLNs using ICG Dye vs Blue Dye at Patient Level
* Report the detection rate of SLNs using ICG dye for sentinel lymph node mapping. * Report the detection rate of SLNs using blue dye for sentinel lymph node mapping. * Compare the two detection rates using a chi-squared test or Fisher's exact test, depending on the sample size.
Time frame: Data collection at time of surgery
Clustered Analysis at the Hemi-Pelvis Level
* Use generalized estimating equations (GEE) or mixed-effects logistic regression models to account for the clustering effect. * Include a random effect for each patient to address the correlation between SLNs within the same patient's hemi-pelvis. * Assess the significance of dye type using the Wald test or likelihood ratio test. * Report odds ratios, confidence intervals, and p-values for the effect of dye type on SLN detection.
Time frame: Data collection at time of surgery
3. Difference in SLNs Detected in Blue vs Green Dye when Data is Clustered at Hemi-Pelvis Level
* Report the proportion of SLNs detected using blue dye in each hemi-pelvis. * Report the proportion of SLNs detected using ICG dye in each hemi-pelvis. * Use a paired t-test or Mcnemar's test to compare the proportions within each hemi-pelvis. * Account for the clustering effect by using mixed-effects models
Time frame: Data collection at time of surgery
Sensitivity, Specificity, and Negative Predictive Value of ICG Dye vs Standard Blue Dye
* Create a 2x2 contingency table for sensitivity, specificity, and negative predictive value. * Sensitivity = (True Positives) / (True Positives + False Negatives). * Specificity = (True Negatives) / (True Negatives + False Positives). * Negative Predictive Value = (True Negatives) / (True Negatives + False Negatives).
Time frame: Data collection at time of surgery
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