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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467219
• Other study ID #: 11-0211-C
• Status: Completed
• Phase: N/A
• First received: October 19, 2011
• Last updated: June 19, 2015
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: June 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Procedure:
• lymphadenectomy
bilateral pelvic and para-aortic lymph node dissection
• therapeutic conventional therapy
hysterectomy, bilateral salpingo-oophorectomy,bilateral pelvic and para-aortic lymph node dissection +/- omentectomy via laparotomy, laparoscopy or robotic-assisted
• 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)

Locations

Country	Name	City	State
Canada	University Health Network - Princess Margaret Cancer Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of metastatic disease in endometrial cancer through pre-operative PET assessment in combination with an FDG intra-operative gamma probe.		2 years	No