Sentinel Lymph Node Mapping in Rectal Cancer

Summary

The purpose of this study is to develop a technique that allows physicians to identify the first lymph nodes draining from a rectal tumor (the sentinel lymph nodes). Currently, there is no technique used to find these lymph nodes in the rectum during surgery and therefore many patients with rectal cancer need to undergo a total rectal resection. Dyes, tracers, imaging and a gamma probe will be used in this study during a standard minimally invasive transanal endoscopic surgery (TES) to try to locate these lymph nodes. If surgeons are able to locate these lymph nodes they will be removed during surgery. If the technique is successfully developed as a result of this research, it could help patients in the future with early stage rectal cancer by allowing doctors to see if their cancer has spread to the lymph nodes of the rectum without having to undergo a total rectal resection. These patients would then be able to undergo a TES combined with a lymph node dissection to gain more knowledge about the stage of their disease. This knowledge would then be used to determine if and what further treatment is necessary for the patient's rectal cancer.

Conditions

• Rectal Neoplasms

Interventions

OTHER

Endoscopic injection of 99mTc-sulfur colloid

Radiotracer injection around the rectal tumor for SLN mapping with gamma probe

OTHER

Endoscopic injection of ICG

Dye injection around the rectal tumor for SLN mapping with NIR imaging.

OTHER

Endoscopic injection of Spot

Dye injection for tattooing rectal tumor prior to surgical resection.

PROCEDURE

Flexible sigmoidoscopy

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

PROCEDURE

Endoscopic NIR imaging and gamma probe

Endoscopic near infrared (NIR) imaging of ICG and detection of radiotracer with gamma probe after standard removal of rectal neoplasm.

PROCEDURE

Dissection of sentinel lymph node(s)

Surgical removal of identified lymph nodes in the rectum.

Sponsors & Collaborators

• University of Virginia

  lead OTHER

Principal Investigators

• Traci 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

2016-08-31

Primary Completion

2019-03-31

Countries

• United States

Study Locations