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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01467219

Enrollment

Registered

2011-11-08

Start date

2012-01-31

Completion date

2014-03-31

Last updated

2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

early, high risk

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.

Interventions

PROCEDUREtherapeutic conventional therapy

hysterectomy, bilateral salpingo-oophorectomy,bilateral pelvic and para-aortic lymph node dissection +/- omentectomy via laparotomy, laparoscopy or robotic-assisted

PROCEDUREPositron Emission Tomography/ Computed Tomography

Pre-operative PET/CT scan

RADIATIONfludeoxyglucose F 18

5 MBq/kg body weight of FDG (up to 550 MBq)

PROCEDURElymphadenectomy

bilateral pelvic and para-aortic lymph node dissection

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Identification of metastatic disease in endometrial cancer through pre-operative PET assessment in combination with an FDG intra-operative gamma probe.	2 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026