Trial Information
Intra-operative Lymph Node Evaluation Using a Hand Held PET Gamma Probe in Endometrial Cancer Surgery - A Pilot Study
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Identification of metastatic disease in endometrial cancer through pre-operative PET assessment in combination with an FDG intra-operative gamma probe.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Marcus Bernardini, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital - University Health Network
Authority:
Canada: Ethics Review Committee
Study ID:
11-0211-C
NCT ID:
NCT01467219
Start Date:
January 2012
Completion Date:
October 2013
Related Keywords:
- Endometrial Cancer
- early
- high risk
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma