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Sentinel Lymph Node Detection in Early Cervical Cancer

NCT02543775 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-06-18

No results posted yet for this study

Summary

The primary objective of this study is to determine the feasibility of detecting the sentinel lymph node (SLN) in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique.

The investigators hypothesize that the sentinel lymph node (first node draining the tumour/cervix) for early stage cervical cancer represents the status of the regional lymph node basin (pelvic lymph nodes) and identification of a negative SLN would negate the need for complete pelvic lymphadenectomy.

Conditions

Interventions

PROCEDURE

Preoperative and intraoperative SLN Mapping

Patients will undergo preoperative SLN mapping, which includes an injection of a radiocolloid and lymphosinctogram and SPECT/CT. Patients will also receive an intraoperative injection of blue dye. A handheld probe will be utilized to detect radiolabelled or "hot" nodes and direct visualization will identify blue nodes which will be labelled "Sentinel Nodes" and sent to pathology for intraoperative frozen section.

Sponsors & Collaborators

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Sarah Ferguson, MD · Princess Margaret Hospital, Canada

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02543775 on ClinicalTrials.gov