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

Rectal Cancer Clinical Trial

Official title:

Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02112240
• Other study ID #: 16746
• Status: Withdrawn
• Phase: N/A
• First received: March 20, 2014
• Last updated: July 14, 2016
• Start date: May 2013

Study information

• Verified date: July 2016
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Feasibility	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.	From the time of tracer and dye injections to 30 day postoperative visit	Yes