Pilot Study Using a PET Gamma Probe to Evaluate Lymph Nodes in Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title: Intra-operative Lymph Node Evaluation Using a Hand Held PET Gamma Probe in Endometrial Cancer Surgery - A Pilot Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT01467219
• Study type: Interventional
• Source: University Health Network, Toronto
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Completion date: March 2014