Brief Title
Pilot Study Using a PET Gamma Probe to Evaluate Lymph Nodes in Endometrial Cancer
Official Title
Intra-operative Lymph Node Evaluation Using a Hand Held PET Gamma Probe in Endometrial Cancer Surgery - A Pilot Study
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.
Study Type
Interventional
Primary Outcome
Identification of metastatic disease in endometrial cancer through pre-operative PET assessment in combination with an FDG intra-operative gamma probe.
Condition
Endometrial Cancer
Intervention
lymphadenectomy
Study Arms / Comparison Groups
PET Probe
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
12
Start Date
January 2012
Completion Date
March 2014
Primary Completion Date
March 2014
Eligibility 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
Gender
Female
Ages
20 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Marcus Bernardini, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01467219
Organization ID
11-0211-C
Responsible Party
Sponsor
Study Sponsor
University Health Network, Toronto
Study Sponsor
Marcus Bernardini, MD, Principal Investigator, Princess Margaret Hospital, University Health Network
Verification Date
June 2015