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NCT Number: NCT01467219

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

20 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network - Princess Margaret Cancer Center

Toronto, Ontario, M5T 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lymphadenectomy

Procedure

bilateral pelvic and para-aortic lymph node dissection

therapeutic conventional therapy

Procedure

hysterectomy, bilateral salpingo-oophorectomy,bilateral pelvic and para-aortic lymph node dissection +/- omentectomy via laparotomy, laparoscopy or robotic-assisted

Positron Emission Tomography/ Computed Tomography

Procedure

Pre-operative PET/CT scan

fludeoxyglucose F 18

Radiation

5 MBq/kg body weight of FDG (up to 550 MBq)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2011
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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