Rochester, Minn.
The purpose of this study is to assess the 36-month incidence of pelvic/non-vaginal recurrence among patients with surgical stage I intermediate-risk endometrial cancer.
Eligible patients presenting with apparent uterine confined grade 1, 2, or 3 endometrioid endometrial cancer will undergo standard-of-care primary surgical treatment with a cervical injection of indocyanine green (ICG) dye for SLN mapping, a total hysterectomy, removal of the adnexae and staging with sentinel node mapping and pelvic washings.
The final assessment for inclusion in the follow-up part of the study will be determined from the results of the final hysterectomy and staging pathology report to ensure bilaterally negative pelvic sentinel nodes and a surgical stage I endometrioid endometrial cancer grade 1 or 2 with 50% or more uterine myoinvasion or grade 3 with less than 50% uterine myoinvasion. Women meeting this criteria will comprise the study cohort and be followed for three years.