Sentinel Lymph Node Mapping in Rectal Cancer

Status unconfirmed · Not applicable

Conditions studied: Rectal Neoplasms

In brief

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.

Key facts

Study ID

NCT02869152

Run by

University of Virginia

People needed

26

Starts

2016-08-01

Last updated by the study team

2016-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Virginia — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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