Sentinel Lymph Node Mapping in Rectal Cancer

University of Virginia

Status: Unknown

Conditions: Rectal Neoplasms

Treatments: Other: Endoscopic injection of 99mTc-sulfur colloid; Procedure: Endoscopic NIR imaging and gamma probe; Other: Endoscopic injection of ICG; Procedure: Dissection of sentinel lymph node(s); Other: Endoscopic injection of Spot; Procedure: Flexible sigmoidoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02869152

19120

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Intraoperative sentinel lymph node mapping

Experimental group

Description:

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.

Treatment:

Other: Endoscopic injection of 99mTc-sulfur colloid

Procedure: Dissection of sentinel lymph node(s)

Other: Endoscopic injection of Spot

Procedure: Flexible sigmoidoscopy

Procedure: Endoscopic NIR imaging and gamma probe

Other: Endoscopic injection of ICG