Sentinel Lymph Node Mapping in Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02869152
• Other study ID #: 19120
• Status: Recruiting
• Phase: N/A
• First received: July 14, 2016
• Last updated: October 27, 2016
• Start date: August 2016

Study information

• Verified date: October 2016
• Source: University of Virginia
• Contact: Amy Harrigan, BS, CCRC
• Phone: 434-982-6532
• Email: acm6a[@]virginia.edu
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Other:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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.	No
Secondary	Size of the SLN according to pathologic analysis		Throughout study, an average of 2.5 years	No
Secondary	Location of the SLN according to pathologic analysis		Throughout study, an average of 2.5 years.	No
Secondary	Time required for completion of the protocol		Throughout study, an average of 2.5 years.	No
Secondary	Number of protocol modifications for procedural and/or technical issues		Throughout study, an average of 2.5 years	No
Secondary	Ergonomic optimization of the protocol as measured by operative time		Throughout study, an average of 2.5 years	No
Secondary	Ergonomic optimization of the protocol as measured by surgeon satisfaction		Throughout study, an average of 2.5 years	No