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Feasibility Study to Develop Sentinel Lymph Node Mapping in Rectal Cancer Patients

NCT02112240 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-07-15

No results posted yet for this study

Summary

The purpose of this study is to see if investigators can develop a technique to identify sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer (Tc-sulfur colloid), a dye (Spot), and imaging, both pre- and intraoperatively. Eligible patients are those with stage I-III rectal cancer undergoing standard low anterior resection or abdominoperineal resection.

Investigators hypothesize that use of a unique intraoperative lymphatic mapping technique using a mobile gamma camera will identify the sentinel lymph node in patients with rectal cancer with greater than 80% sensitivity.

Subjects will receive injections of the tracer and dye prior to surgery, have preoperative SPECT/CT imaging to be used as a guide to the rectal lymphatic system and then proceed to their scheduled surgery. During surgery, images of the rectum will be taken with a unique mobile gamma camera prior to removal and upon resection.

If surgeons are able to identify the sentinel lymph nodes surrounding the rectal tumor, the hope is to combine this technique with a less invasive surgery called transanal endoscopic microsurgery (TEM) for early stage rectal cancer patients.

Conditions

Interventions

OTHER

Intraoperative Mobile Gamma Camera imaging

Intraoperative images will be taken with a unique mobile gamma camera to identify sentinel lymph nodes in the rectum.

DRUG

Endoscopic injection of 99mTc-sulfur colloid

Radiotracer injection around the rectal tumor for pre- and intra-operative imaging.

OTHER

Endoscopic injections of Spot

Dye injection for tattooing rectal tumor prior to surgical resection.

PROCEDURE

Preoperative flexible sigmoidoscopy

Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dye.

RADIATION

SPECT/CT

Preoperative imaging to identify lymph nodes in rectum.

Sponsors & Collaborators

  • American Cancer Society, Inc.

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • Traci L Hedrick, MD · University of Virginia

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2017-02-28

Countries

  • United States

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 NCT02112240 on ClinicalTrials.gov