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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2016

Completed

18 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed

15 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed

Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

July 14, 2016

Last Update Submit

October 27, 2016

Conditions

Rectal Neoplasms

Keywords

sentinel lymph nodelymphatic mappingrectal tumorrectal cancerearly stage

Outcome Measures

Primary Outcomes (2)

1st Phase: Detection rate of sentinel lymph node in first 6 patients
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
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 Outcomes (6)

Size of the SLN according to pathologic analysis
Throughout study, an average of 2.5 years
Location of the SLN according to pathologic analysis
Throughout study, an average of 2.5 years.
Time required for completion of the protocol
Throughout study, an average of 2.5 years.
Number of protocol modifications for procedural and/or technical issues
Throughout study, an average of 2.5 years
Ergonomic optimization of the protocol as measured by operative time
Throughout study, an average of 2.5 years
+1 more secondary outcomes

Study Arms (1)

Intraoperative sentinel lymph node mapping

EXPERIMENTAL

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 colloidOther: Endoscopic injection of ICGOther: Endoscopic injection of SpotProcedure: Flexible sigmoidoscopyProcedure: Endoscopic NIR imaging and gamma probeProcedure: Dissection of sentinel lymph node(s)