Rectal Cancer
Conditions
Keywords
sentinel lymph node, lymphatic mapping, rectal tumor
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.
Interventions
OTHERIntraoperative Mobile Gamma Camera imaging
Intraoperative images will be taken with a unique mobile gamma camera to identify sentinel lymph nodes in the rectum.
Radiotracer injection around the rectal tumor for pre- and intra-operative imaging.
OTHEREndoscopic injections of Spot
Dye injection for tattooing rectal tumor prior to surgical resection.
PROCEDUREPreoperative flexible sigmoidoscopy
Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dye.
RADIATIONSPECT/CT
Preoperative imaging to identify lymph nodes in rectum.
Sponsors
American Cancer Society, Inc.
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating the sensitivity of identifying the sentinel lymph node using a unique mobile gamma camera intraoperatively. | At the time of surgery and the time of pathological review, an expected average of 7 days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | From the time of tracer and dye injections to 30 day postoperative visit | Descriptive summaries will be used to list any complications that may have occurred pre-, intra- or post-operatively. Frequency and location of the sentinel lymph node (SLN) with respect to the tumor prior to surgery will be noted. In addition the location of the SLN in relation to the tumor will be documented during pathologic examination with the pathologist and surgeon to assess the feasibility of excision with transanal endoscopic microsurgery. |
Countries
United States
Outcome results
None listed