NCT02112240

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

Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Rectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-02-01
• First posted: 2014-04-11
• Last updated: 2016-07-15

Locations

1 site across 1 country: United States