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

Not Applicable

Completed

• Conditions: Endometrial Cancer
• Interventions: Procedure: lymphadenectomy; Procedure: therapeutic conventional therapy; Procedure: Positron Emission Tomography/ Computed Tomography; Radiation: fludeoxyglucose F 18

• Registration Number: NCT01467219
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-08
• Study Start: 2012-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-19
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

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Exclusion Criteria

• Patients with previous retroperitoneal surgery
• Patients with previous history of pelvic/abdominal radiation
• Any patient treated with neoadjuvant chemotherapy and/or radiation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET Probe	lymphadenectomy	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.
PET Probe	therapeutic conventional therapy	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.
PET Probe	fludeoxyglucose F 18	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.
PET Probe	Positron Emission Tomography/ Computed Tomography	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.

Primary Outcome Measures

Name	Time	Method
Identification of metastatic disease in endometrial cancer through pre-operative PET assessment in combination with an FDG intra-operative gamma probe.	2 years

Trial Locations

Locations (1)

University Health Network - Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada