Accuracy of Sentinel Lymph Node Biopsy and Gadofosveset-Enhanced MR in Nodal Staging of High Risk Endometrial Cancer (Ablavar)
The standard of care for women with high risk endometrial cancer is the removal of all visible lymph nodes in the pelvis and lower abdomen to identify if disease has spread to these areas. It is estimated that no more than 25% of all women with presumed early stage high risk endometrial cancer will have positive lymph nodes however currently the majority of women are subjected to extensive resection of all pelvic lymph and or para-aortic lymph nodes and its associated morbidities. The objective of this study is to determine if the combination of preoperative MR imaging with intraoperative sentinel lymph node (SLN) mapping will improve the assessment of regional lymph nodes and enhance the detection of lymph nodes with metastatic disease in endometrial cancer. This would benefit the majority of women with early stage high risk endometrial cancer and would prevent the associated complications of pelvic lymph node dissection.
High Grade Endometrial Cancer
Sentinel Lymph Node Mapping
Biological: Gadofosveset Trisodium (Ablavar)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Accuracy of Sentinel Lymph Node Biopsy and Gadofosveset-Enhanced MR in Nodal Staging of High Risk Endometrial Cancer: A Prospective Trial|
- Performance Analysis [ Time Frame: Year 3 ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: Gadofosveset Trisodium (Ablavar)
Ablavar (Gadofosveset Trisodium) will be used as an MRI contrast agent to identify metastatic lymph nodes prior to surgery. The contrast agent solution will be administered intravenously at a dose of 0.12mL/kg bodyweight.
|Biological: Gadofosveset Trisodium (Ablavar)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886066
|Contact: Sarah Ferguson, MD||416-946-4501 ext 6597||Sarah.Ferguson@uhn.ca|
|Contact: Safia Nazarali||416-946-4501 ext 3969||Safia.Nazarali@uhn.ca|
|Sunnybrook Health Sciences Center||Recruiting|
|Toronto, Ontario, Canada, M4N3M5|
|Contact: Danielle Vicus, MD 416-480-4378 ext 4026 email@example.com|
|University Health Network - Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5T 2M9|
|Contact: Sarah Ferguson, MD 416-946-4501 ext 6597 Sarah.Ferguson@uhn.ca|
|Contact: Safia Nazarali 416-946-4501 ext 3969 Safia.Nazarali@uhn.ca|