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


N/A
20 Years
90 Years
Open (Enrolling)
Female
Endometrial Cancer

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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

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