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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01467219
First received: October 19, 2011
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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 ]

Estimated Enrollment: 18
Study Start Date: January 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Marcus Bernardini, MD 416 946 4501 ext 2668 marcus.bernardini@uhn.ca
Contact: Ria Sayat, MSc. 416 946-4501 ext 4658 ria.sayat@uhn.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Ria Sayat, MSc.    416-946-4501 ext 4658    ria.sayat@uhn.ca   
Principal Investigator: Marcus Bernardini, MD         
Principal Investigator: Sarah Ferguson, MD         
Principal Investigator: Ur Metser, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Marcus Bernardini, MD Princess Margaret Hospital - University Health Network
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01467219     History of Changes
Other Study ID Numbers: 11-0211-C
Study First Received: October 19, 2011
Last Updated: May 14, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
early
high risk

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on July 29, 2014