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

This study has been completed.
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
First received: October 19, 2011
Last updated: June 19, 2015
Last verified: June 2015

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.

Condition Intervention
Endometrial Cancer
Procedure: lymphadenectomy
Procedure: therapeutic conventional therapy
Procedure: Positron Emission Tomography/ Computed Tomography
Radiation: fludeoxyglucose F 18

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: January 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET Probe
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
bilateral pelvic and para-aortic lymph node dissection
Procedure: therapeutic conventional therapy
hysterectomy, bilateral salpingo-oophorectomy,bilateral pelvic and para-aortic lymph node dissection +/- omentectomy via laparotomy, laparoscopy or robotic-assisted
Procedure: Positron Emission Tomography/ Computed Tomography
Pre-operative PET/CT scan
Radiation: fludeoxyglucose F 18
5 MBq/kg body weight of FDG (up to 550 MBq)


Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01467219

Canada, Ontario
University Health Network - Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5T 2M9
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Marcus Bernardini, MD Princess Margaret Hospital - University Health Network
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01467219     History of Changes
Other Study ID Numbers: 11-0211-C
Study First Received: October 19, 2011
Last Updated: June 19, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
high risk

Additional relevant MeSH terms:
Endometrial Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms
Fluorodeoxyglucose F18
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2015