Pilot Study Using a PET Gamma Probe to Evaluate Lymph Nodes in Endometrial Cancer
The surgical management of high-risk endometrial cancer often involves an extensive operation to remove lymph nodes as sites of possible cancer spread.
18F-FDG PET/CT imaging is increasingly being used to identify sites of cancer spread and recently groups have used an intra-operative gamma probe to better localize metastatic disease. In this pilot study, patients with newly diagnosed early stage, high-risk endometrial cancer undergoing primary surgery will have a pre-operative PET scan and intra-operative localization of metastatic lymph nodes with the use of a gamma probe. A complete lymphadenectomy will follow and ability to detect positive lymph nodes of both PET scan and the intra-operative probe will be calculated.
This study addresses the feasibility of an FDG detection gamma probe in addition to a pre-operative PET/CT for lymphatic mapping in women with clinical early stage high risk endometrial cancer. The study will also evaluate the role of identifying metastatic lymph nodes intraoperatively that would otherwise be clinically negative.
Procedure: therapeutic conventional therapy
Procedure: Positron Emission Tomography/ Computed Tomography
Radiation: fludeoxyglucose F 18
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Intra-operative Lymph Node Evaluation Using a Hand Held PET Gamma Probe in Endometrial Cancer Surgery - A Pilot Study|
- Identification of metastatic disease in endometrial cancer through pre-operative PET assessment in combination with an FDG intra-operative gamma probe. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: PET Probe
Patients will receive an IV injection of approximately 5 MBq/kg body weight of 18F-FDG (Fludeoxyglucose) (up to 550 MBq). Following injection, patients will undergo CT and PET scans. Intraoperatively, a hand held gamma counter will be used to identify "hot" lymph nodes.
bilateral pelvic and para-aortic lymph node dissectionProcedure: therapeutic conventional therapy
hysterectomy, bilateral salpingo-oophorectomy,bilateral pelvic and para-aortic lymph node dissection +/- omentectomy via laparotomy, laparoscopy or robotic-assistedProcedure: Positron Emission Tomography/ Computed Tomography
Pre-operative PET/CT scanRadiation: fludeoxyglucose F 18
5 MBq/kg body weight of FDG (up to 550 MBq)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467219
|University Health Network - Princess Margaret Cancer Center|
|Toronto, Ontario, Canada, M5T 2M9|
|Principal Investigator:||Marcus Bernardini, MD||Princess Margaret Hospital - University Health Network|