Pilot Study Using a PET Gamma Probe to Evaluate Lymph Nodes in Endometrial Cancer
NCT ID: NCT01467219
Last Updated: 2015-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2012-01-31
2014-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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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.
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
fludeoxyglucose F 18
5 MBq/kg body weight of FDG (up to 550 MBq)
Interventions
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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
fludeoxyglucose F 18
5 MBq/kg body weight of FDG (up to 550 MBq)
Eligibility Criteria
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Inclusion Criteria
* 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 history of pelvic/abdominal radiation
* Any patient treated with neoadjuvant chemotherapy and/or radiation
20 Years
90 Years
FEMALE
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Marcus Bernardini, MD
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Hospital, University Health Network
Locations
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University Health Network - Princess Margaret Cancer Center
Toronto, Ontario, Canada
Countries
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Other Identifiers
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11-0211-C
Identifier Type: -
Identifier Source: org_study_id
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