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|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Contact: Marcus Bernardini, MD||416 946 4501 ext firstname.lastname@example.org|
|Contact: Ria Sayat, MSc.||416 946-4501 ext email@example.com|
|Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Ria Sayat, MSc. 416-946-4501 ext 4658 firstname.lastname@example.org|
|Principal Investigator: Marcus Bernardini, MD|
|Principal Investigator: Sarah Ferguson, MD|
|Principal Investigator: Ur Metser, MD|
|Principal Investigator:||Marcus Bernardini, MD||Princess Margaret Hospital - University Health Network|