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



Status:Withdrawn
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/16/2016
Start Date:May 2013

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Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer

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.


Inclusion Criteria:

- Adult patients with stage I,II, or III rectal cancer undergoing standard trans-
abdominal low anterior resection or abdominoperineal resection surgery at the
University of Virginia

- Willing and able to give written informed consent

Exclusion Criteria:

- Patients less than 18 years of age

- Women who are pregnant and/or breastfeeding

- Prisoners

- Unable to give written informed consent

- Participants with medical contradictions or have potential problems complying with
the requirements of the protocol, in the opinion of the investigator
We found this trial at
1
site
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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