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Accuracy of Sentinel Lymph Node Biopsy and Gadofosveset-Enhanced MR in Nodal Staging of High Risk Endometrial Cancer: A Prospective Trial


N/A
18 Years
N/A
Open (Enrolling)
Female
High Grade Endometrial Cancer, Sentinel Lymph Node Mapping, Ablavar

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Trial Information

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.


Inclusion Criteria:



- Women with endometrial cancer with high risk histologic subtypes including
carcinosarcoma, grade 3 endometrioid, serous, clear cell, undifferentiated
adenocarcinoma

- Clinical stage 1 disease- no evidence of metastatic disease beyond the uterus by
physical exam or preoperative imaging if performed.

- Patients who have signed an approved informed consent.

- Patients who will undergo surgery that includes a abdominal hysterectomy and
bilateral pelvic and inframesenteric para-aortic lymphadenectomy via laparotomy,
laparoscopy or robotic-assisted.

Exclusion Criteria:

- Patients with evidence of metastatic disease on preoperative imaging.

- Patients with evidence of intraperitoneal metastatic disease intraoperatively
(patients with suspicious retroperitoneal lymph nodes intraoperatively will still be
included).

- Patients with known allergy to triphenylmethane compounds.

- Contraindications for MRI: The contraindications for MR are as per departmental
safety guidelines. Specifically patients with cardiac pacemaker, cochlear implants,
insulin pumps, nerve stimulators, lead wires, prosthetic heart valves or haemostatic
clips will be excluded.

- Contraindications for contrast (Gadovosfeset trisodium):

1. History of a prior allergic reaction to a gadolinium-based contrast agent.

2. High risk for nephrogenic systemic fibrosis. The precautions as per routine
departmental protocol for use of Gadolinium-based contrast agent will be
applied (For the purpose of this study, patients with eGFR less than 30 will be
excluded from the study).

3. Patients with documented prolonged QTc.

- Pregnant patient.

- Patients with previous retroperitoneal surgery.

- Patients with previous history of pelvic/abdominal radiation.

- Patients with recurrent endometrial cancer.

- Any patient treated with neoadjuvant chemotherapy and/or radiation.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Performance Analysis

Outcome Description:

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.

Outcome Time Frame:

Year 3

Safety Issue:

No

Authority:

Canada: University Health Network Research Ethics Board

Study ID:

12-0257-C

NCT ID:

NCT01886066

Start Date:

March 2012

Completion Date:

March 2015

Related Keywords:

  • High Grade Endometrial Cancer
  • Sentinel Lymph Node Mapping
  • Ablavar
  • Endometrial cancer
  • Sentinel lymph node
  • Ablavar
  • Sentinel lymph node mapping
  • Sentinel lymph node identification
  • Technetium
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

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