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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01467219
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : June 23, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Procedure: lymphadenectomy Procedure: therapeutic conventional therapy Procedure: Positron Emission Tomography/ Computed Tomography Radiation: fludeoxyglucose F 18 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Intra-operative Lymph Node Evaluation Using a Hand Held PET Gamma Probe in Endometrial Cancer Surgery - A Pilot Study
Study Start Date : January 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: University Health Network, Toronto Identifier: NCT01467219     History of Changes
Other Study ID Numbers: 11-0211-C
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by University Health Network, Toronto:
high risk

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