Intra-operative Lymph Node Evaluation Using a Hand Held PET Gamma Probe in Endometrial Cancer Surgery - A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Cancer
- Sponsor
- University Health Network, Toronto
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Identification of metastatic disease in endometrial cancer through pre-operative PET assessment in combination with an FDG intra-operative gamma probe.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women with adenocarcinoma of the endometrium with one of the following subtypes:
- •Clear Cell
- •Carcinosarcoma (MMMT)
- •High grade endometrioid
- •Clinical stage 1 or 2
- •Patients who have signed an approved informed consent.
- •Patients who will undergo surgery that includes a hysterectomy and/or hysterectomy, bilateral salpingo-oophorectomy, bilateral pelvic and para-aortic lymph node
Exclusion Criteria
- •Patients with previous retroperitoneal surgery
- •Patients with previous history of pelvic/abdominal radiation
- •Any patient treated with neoadjuvant chemotherapy and/or radiation
Outcomes
Primary Outcomes
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