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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Procedure: lymphadenectomy
* Procedure: therapeutic conventional therapy
* Procedure: Positron Emission Tomography/ Computed Tomography
* Radiation: fludeoxyglucose F 18


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with adenocarcinoma of the endometrium with one of the following subtypes: Serous 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET Probe<br>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. | Procedure: lymphadenectomy<br>* bilateral pelvic and para-aortic lymph node dissection<br>Procedure: therapeutic conventional therapy<br>* hysterectomy, bilateral salpingo-oophorectomy,bilateral pelvic and para-aortic lymph node dissection +/- omentectomy via laparotomy, laparoscopy or robotic-assisted<br>Procedure: Positron Emission Tomography/ Computed Tomography<br>* Pre-operative PET/CT scan<br>Radiation: fludeoxyglucose F 18<br>* 5 MBq/kg body weight of FDG (up to 550 MBq)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of metastatic disease in endometrial cancer through pre-operative PET assessment in combination with an FDG intra-operative gamma probe. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early, high risk