Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach

1 country

1 active site

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed

22 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed

Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

3.8 years

First QC Date

March 20, 2014

Last Update Submit

July 14, 2016

Conditions

Rectal Cancer

Keywords

sentinel lymph nodelymphatic mappingrectal tumor

Outcome Measures

Primary Outcomes (1)

Evaluating the sensitivity of identifying the sentinel lymph node using a unique mobile gamma camera intraoperatively.
The primary endpoint is the sensitivity of sentinel lymph node (SLN) detection by the technique which will be estimated by the number of SLNs detected by the technique divided by the number noted at surgery or on final pathology review. 90% confidences interval around the estimate will help guide interpretation of the results.
At the time of surgery and the time of pathological review, an expected average of 7 days.

Secondary Outcomes (1)

Feasibility
From the time of tracer and dye injections to 30 day postoperative visit

Study Arms (1)

Surgery with pre- and intra-op imaging

EXPERIMENTAL

Subjects will have a preoperative flexible sigmoidoscopy where they will receive an endoscopic injection of 99mTc-sulfur colloid (up to 0.5 mCi) and 3 to 5 cc of circumferential endoscopic injections of Spot. A SPECT/CT will be performed prior to surgery to identify lymph nodes in the rectum. Subjects will proceed to their standard surgery. Intraoperative mobile gamma camera imaging of the rectum will occur before and after resection in attempt to identify sentinel lymph nodes.

Other: Intraoperative Mobile Gamma Camera imagingDrug: Endoscopic injection of 99mTc-sulfur colloidOther: Endoscopic injections of SpotProcedure: Preoperative flexible sigmoidoscopyRadiation: SPECT/CT

Interventions

Intraoperative Mobile Gamma Camera imagingOTHER

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