Accuracy of Sentinel Lymph Node Biopsy and Gadofosveset-Enhanced MR in Nodal Staging of High Risk Endometrial Cancer (Ablavar)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
Safia Nazarali, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01886066
First received: June 20, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

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.


Condition Intervention
High Grade Endometrial Cancer
Sentinel Lymph Node Mapping
Ablavar
Biological: Gadofosveset Trisodium (Ablavar)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886066

Contacts
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

Locations
Canada, Ontario
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   
Sunnybrook Health Sciences Center Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Danielle Vicus, MD    416-480-4378 ext 4026    danielle.vicus@sunnybrook.ca   
Sponsors and Collaborators
University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Safia Nazarali, Clinical Research Associate, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01886066     History of Changes
Other Study ID Numbers: 12-0257-C
Study First Received: June 20, 2013
Last Updated: June 20, 2013
Health Authority: Canada: University Health Network Research Ethics Board

Keywords provided by University Health Network, Toronto:
Endometrial cancer
Sentinel lymph node
Ablavar
Sentinel lymph node mapping
Sentinel lymph node identification
Technetium

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on July 22, 2014