Sentinel Lymph Node Mapping in Rectal Cancer

October 27, 2016 updated by: Traci Hedrick, MD, University of Virginia

Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer

The purpose of this study is to develop a technique that allows physicians to identify the first lymph nodes draining from a rectal tumor (the sentinel lymph nodes). Currently, there is no technique used to find these lymph nodes in the rectum during surgery and therefore many patients with rectal cancer need to undergo a total rectal resection. Dyes, tracers, imaging and a gamma probe will be used in this study during a standard minimally invasive transanal endoscopic surgery (TES) to try to locate these lymph nodes. If surgeons are able to locate these lymph nodes they will be removed during surgery. If the technique is successfully developed as a result of this research, it could help patients in the future with early stage rectal cancer by allowing doctors to see if their cancer has spread to the lymph nodes of the rectum without having to undergo a total rectal resection. These patients would then be able to undergo a TES combined with a lymph node dissection to gain more knowledge about the stage of their disease. This knowledge would then be used to determine if and what further treatment is necessary for the patient's rectal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • Traci L Hedrick, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients undergoing elective transanal endoscopic surgery (TES) at the University of Virginia for rectal neoplasm (polyp with high grade dysplasia, T1N0 tumors < 3cm in the absence of poor pathologic features, patients that refuse radical resection)
  • 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

  • Patients with any of the following:

    • Allergy to technetium, Spot and/or ICG
    • Allergy to iodides
    • Severe cardiac disease (hospitalization for cardiac disease in the last year, congestive heart failure, abnormal EKG) or renal disease (Creatinine > 2.0 mg/dL)
  • Patients with medical contradictions or have potential problems complying with the requirements of the protocol, in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoperative sentinel lymph node mapping
Subjects will come to the OR and undergo a flexible sigmoidoscopy after induction of anesthesia and receive separate endoscopic injections of Spot (up to 5 cc), 99mTc-sulfur colloid (up to 0.5 mCi), and Indocyanine green (ICG) (1 ml). Patient will undergo the standard transanal endoscopic surgery (TES) to remove the rectal neoplasm, exposing the lymph node basin. The sentinel node(s) will be identified using a combination of the gamma probe and fluorescence imaging endoscopically, dissected out, and removed through a transanal approach.
Other: Endoscopic injection of 99mTc-sulfur colloid
Radiotracer injection around the rectal tumor for SLN mapping with gamma probe
Other: Endoscopic injection of ICG
Dye injection around the rectal tumor for SLN mapping with NIR imaging.
Other: Endoscopic injection of Spot
Dye injection for tattooing rectal tumor prior to surgical resection.
Procedure: Flexible sigmoidoscopy
Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dyes.
Procedure: Endoscopic NIR imaging and gamma probe
Endoscopic near infrared (NIR) imaging of ICG and detection of radiotracer with gamma probe after standard removal of rectal neoplasm.
Procedure: Dissection of sentinel lymph node(s)
Surgical removal of identified lymph nodes in the rectum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1st Phase: Detection rate of sentinel lymph node in first 6 patients
Time Frame: Throughout first phase of study, an average of 1 year.
Data from the first 6 eligible patients will be used to verify feasibility. For this phase, the data need to support a detection rate of at least 50% for the procedure to be considered feasible to move forward with the 2nd phase. The proposed SLNm technique will be declared 'feasible' if at least one SLN is identified per patient. Identification of the SLN in three consecutive patients would provide 80% confidence of successful identification more than 50% of the time. A total sample of size of 6 patients would allow for three refinements in technique if necessary to establish feasibility.
Throughout first phase of study, an average of 1 year.
2nd Phase: Detection rate of refined protocol in identifying SLN
Time Frame: Throughout first phase of study, an average of 1.5 years.
2nd Phase: Sample size is set at 16 eligible patients. For this study, continued investigation of the proposed technique would be of interest if 70-100% of the SLNs are detected. If at least on SLN is detected in 14 of 16 patients, an observed rate of 87.5%, then the lower limit of a one-sided 90% confidence interval is 70%. Thus, detection of at least one SLN in 14 or more patients out of 16 assessed would provide strong preliminary data for the technique (i.e. SLN is detected in at least 70% of patients). If it's assumed, on average, 1.5 SLN could be identified and excised per patient, then with 24 possible SLN, the estimated rate of SLN positive for disease would have an expected half width (or precision of the estimate) of 12-14%.
Throughout first phase of study, an average of 1.5 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Size of the SLN according to pathologic analysis
Time Frame: Throughout study, an average of 2.5 years
Throughout study, an average of 2.5 years
Location of the SLN according to pathologic analysis
Time Frame: Throughout study, an average of 2.5 years.
Throughout study, an average of 2.5 years.
Time required for completion of the protocol
Time Frame: Throughout study, an average of 2.5 years.
Throughout study, an average of 2.5 years.
Number of protocol modifications for procedural and/or technical issues
Time Frame: Throughout study, an average of 2.5 years
Throughout study, an average of 2.5 years
Ergonomic optimization of the protocol as measured by operative time
Time Frame: Throughout study, an average of 2.5 years
Throughout study, an average of 2.5 years
Ergonomic optimization of the protocol as measured by surgeon satisfaction
Time Frame: Throughout study, an average of 2.5 years
Throughout study, an average of 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Traci Hedrick, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Neoplasms

Clinical Trials on Endoscopic injection of 99mTc-sulfur colloid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe