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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Virginia
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Traci Hedrick, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT02112240
First received: March 20, 2014
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Rectal Cancer
Other: Intraoperative Mobile Gamma Camera imaging
Drug: Endoscopic injection of 99mTc-sulfur colloid
Other: Endoscopic injections of Spot
Procedure: Preoperative flexible sigmoidoscopy
Radiation: SPECT/CT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Evaluating the sensitivity of identifying the sentinel lymph node using a unique mobile gamma camera intraoperatively. [ Time Frame: At the time of surgery and the time of pathological review, an expected average of 7 days. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Feasibility [ Time Frame: From the time of tracer and dye injections to 30 day postoperative visit ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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 Name: Tc-sulfur colloid
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112240

Contacts
Contact: Amy Harrigan, BS 434-982-6532

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Amy Harrigan, BS    434-982-6532      
Principal Investigator: Traci L Hedrick, MD         
Sponsors and Collaborators
University of Virginia
American Cancer Society, Inc.
Investigators
Principal Investigator: Traci L Hedrick, MD University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: Traci Hedrick, MD, Assistant Professor of Surgery, University of Virginia
ClinicalTrials.gov Identifier: NCT02112240     History of Changes
Other Study ID Numbers: 16746
Study First Received: March 20, 2014
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
sentinel lymph node
lymphatic mapping
rectal tumor

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 20, 2014