Accuracy of Sentinel Lymph Node Biopsy and Gadofosveset-Enhanced MR in Nodal Staging of High Risk Endometrial Cancer: A Prospective Trial
If the SLN can be accurately identified and the detection of metastatic lymph nodes in women
with early stage high risk endometrial cancer can be improved then the majority of women
could avoid a complete systematic pelvic lymphadenectomy. Pelvic lymphadenectomy is
associated with many intraoperative and postoperative complications such as hemorrhage,
lymphocyst formation, nerve injury and chronic lower extremity lymphedema. If less invasive
techniques to assess regional lymph node involvement, such as preoperative imaging
techniques and SLN mapping, replaced routine pelvic lymphadenectomy the complications
associated with more extensive pelvic surgery could be avoided.
This will be a prospective cohort study. The population to be studied will be patients with
newly diagnosed early stage high risk endometrial cancer who will undergo primary surgical
intervention that includes hysterectomy and bilateral pelvic and inframesenteric para-aortic
lymphadenectomy via laparotomy, laparoscopy or robotic-assisted. Patients will have a
preoperative Gadofoveset trisodium (Ablavar)-enhanced MRI within 4 weeks of their surgery.
On the morning of surgery, preoperative injection of a radiolabeled colloid will occur in
the Nuclear Medicine Dept. All patients will have preoperative SPECT/CT performed for
preoperative mapping. Patients will be taken to the operating room for their planned
procedure. After initiation of general anesthesia, blue dye will be injected into the
patient's cervix. The surgery will proceed and all lymph nodes that are "blue" and/or "hot"
will be removed surgically and their anatomic location and laterality documented. The
hysterectomy and lymphadenectomy will then be performed. The SLN status will be compared to
the status of the other nodes removed at complete lymphadenectomy. All data on these
patients will be prospectively collected.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Performance analyses of SLN and Ablavar-enhanced MR will be performed. In particular, sensitivity, specificity, and predictive accuracy of SLN and Ablavar-enhanced MRI in the mapping and detection of lymph nodes with metastatic disease will be calculated using the pathology results of the surgical intervention as the Standard of Reference. Performance analyses will be evaluated at both the lesion and patient level. Generalized estimating equations will be used to adjust for correlations of repeated measures within patients. Raw performance estimates will be reported with adjusted 95% confidence intervals.
Canada: University Health Network Research Ethics Board