Feasibility Study to Develop Sentinel Lymph Node Mapping in Rectal Cancer Patients
NCT ID: NCT02112240
Last Updated: 2016-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Surgery with pre- and intra-op imaging
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.
Intraoperative Mobile Gamma Camera imaging
Intraoperative images will be taken with a unique mobile gamma camera to identify sentinel lymph nodes in the rectum.
Endoscopic injection of 99mTc-sulfur colloid
Radiotracer injection around the rectal tumor for pre- and intra-operative imaging.
Endoscopic injections of Spot
Dye injection for tattooing rectal tumor prior to surgical resection.
Preoperative flexible sigmoidoscopy
Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dye.
SPECT/CT
Preoperative imaging to identify lymph nodes in rectum.
Interventions
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Intraoperative Mobile Gamma Camera imaging
Intraoperative images will be taken with a unique mobile gamma camera to identify sentinel lymph nodes in the rectum.
Endoscopic injection of 99mTc-sulfur colloid
Radiotracer injection around the rectal tumor for pre- and intra-operative imaging.
Endoscopic injections of Spot
Dye injection for tattooing rectal tumor prior to surgical resection.
Preoperative flexible sigmoidoscopy
Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dye.
SPECT/CT
Preoperative imaging to identify lymph nodes in rectum.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to give written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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American Cancer Society, Inc.
OTHER
University of Virginia
OTHER
Responsible Party
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Traci Hedrick, MD
Assistant Professor of Surgery
Principal Investigators
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Traci L Hedrick, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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16746
Identifier Type: -
Identifier Source: org_study_id
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