Clinical trial NCT02869152: Sentinel Lymph Node Mapping in Rectal Cancer
Official title: Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Neoplasms
Keywords: sentinel lymph node
lymphatic mapping
rectal tumor
rectal cancer
early stage
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 1st Phase: Detection rate of sentinel lymph node in first 6 patients
timeFrame: Throughout first phase of study, an average of 1 year.
measure: 2nd Phase: Detection rate of refined protocol in identifying SLN
timeFrame: Throughout first phase of study, an average of 1.5 years.
Secondary outcomes:
measure: Size of the SLN according to pathologic analysis
timeFrame: Throughout study, an average of 2.5 years
measure: Location of the SLN according to pathologic analysis
timeFrame: Throughout study, an average of 2.5 years.
measure: Time required for completion of the protocol
timeFrame: Throughout study, an average of 2.5 years.
measure: Number of protocol modifications for procedural and/or technical issues
timeFrame: Throughout study, an average of 2.5 years
measure: Ergonomic optimization of the protocol as measured by operative time
timeFrame: Throughout study, an average of 2.5 years
measure: Ergonomic optimization of the protocol as measured by surgeon satisfaction
timeFrame: Throughout study, an average of 2.5 years
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Traci Hedrick, MD
role: PRINCIPAL_INVESTIGATOR
References: