Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT02869152

Conditions

Rectal Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic injection of 99mTc-sulfur colloid

Endoscopic injection of ICG

Endoscopic injection of Spot

Flexible sigmoidoscopy

Endoscopic NIR imaging and gamma probe

Study Details

Brief summary:

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.

Conditions

Rectal Neoplasms

Study ID

NCT02869152

Start date

Aug, 2016

Status verified date

Oct, 2016

Primary completion date

Mar, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Endoscopic injection of 99mTc-sulfur colloid

Radiotracer injection around the rectal tumor for SLN mapping with gamma probe

Endoscopic injection of ICG

Dye injection around the rectal tumor for SLN mapping with NIR imaging.

Endoscopic injection of Spot

Dye injection for tattooing rectal tumor prior to surgical resection.

Flexible sigmoidoscopy

Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dyes.

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.

Dissection of sentinel lymph node(s)

Surgical removal of identified lymph nodes in the rectum.

Primary outcome measure

  • 1st Phase: Detection rate of sentinel lymph node in first 6 patients [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Amy Harrigan, BS, CCRC

434-982-6532acm6a@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Amy Harrigan

434-982-6532acm6a@virginia.edu

Principal Investigator:

Traci L Hedrick, MD, MS

More Information

Sponsor

University of Virginia

Last update posted

Oct 31, 2016

Last verified

Oct, 2016

Keywords

  • sentinel lymph node
  • lymphatic mapping
  • rectal tumor
  • rectal cancer
  • early stage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2016-10-31.