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

NCT01467219 | Completed

• 1 other identifier: 11-0211-C
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

early; high risk

Outcome Measures

Primary Outcomes (1)

• Identification of metastatic disease in endometrial cancer through pre-operative PET assessment in combination with an FDG intra-operative gamma probe.

  2 years

Study Arms (1)

PET Probe

EXPERIMENTAL

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.

Procedure: lymphadenectomy; Procedure: therapeutic conventional therapy; Procedure: Positron Emission Tomography/ Computed Tomography; Radiation: fludeoxyglucose F 18

Interventions

lymphadenectomy PROCEDURE

bilateral pelvic and para-aortic lymph node dissection

PET Probe

therapeutic conventional therapy PROCEDURE

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

PET Probe

Positron Emission Tomography/ Computed Tomography PROCEDURE

Pre-operative PET/CT scan

PET Probe

fludeoxyglucose F 18 RADIATION

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

PET Probe

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with previous retroperitoneal surgery
• Patients with previous history of pelvic/abdominal radiation
• Any patient treated with neoadjuvant chemotherapy and/or radiation

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network - Princess Margaret Cancer Center

Toronto, Ontario, M5T 2M9, Canada

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Lymph Node Excision; Magnetic Resonance Spectroscopy; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Marcus Bernardini, MD

  Princess Margaret Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: November 8, 2011
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

CA (1)