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Sentinel Lymph Node Mapping in Rectal Cancer

NCT ID: NCT02869152

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Neoplasms

Keywords

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sentinel lymph node lymphatic mapping rectal tumor rectal cancer early stage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intraoperative sentinel lymph node mapping

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.

Group Type EXPERIMENTAL

Endoscopic injection of 99mTc-sulfur colloid

Intervention Type OTHER

Radiotracer injection around the rectal tumor for SLN mapping with gamma probe

Endoscopic injection of ICG

Intervention Type OTHER

Dye injection around the rectal tumor for SLN mapping with NIR imaging.

Endoscopic injection of Spot

Intervention Type OTHER

Dye injection for tattooing rectal tumor prior to surgical resection.

Flexible sigmoidoscopy

Intervention Type PROCEDURE

Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dyes.

Endoscopic NIR imaging and gamma probe

Intervention Type PROCEDURE

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)

Intervention Type PROCEDURE

Surgical removal of identified lymph nodes in the rectum.

Interventions

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Endoscopic injection of 99mTc-sulfur colloid

Radiotracer injection around the rectal tumor for SLN mapping with gamma probe

Intervention Type OTHER

Endoscopic injection of ICG

Dye injection around the rectal tumor for SLN mapping with NIR imaging.

Intervention Type OTHER

Endoscopic injection of Spot

Dye injection for tattooing rectal tumor prior to surgical resection.

Intervention Type OTHER

Flexible sigmoidoscopy

Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dyes.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Dissection of sentinel lymph node(s)

Surgical removal of identified lymph nodes in the rectum.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Traci Hedrick, MD

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Traci Hedrick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amy Harrigan, BS, CCRC

Role: CONTACT

Phone: 434-982-6532

Email: [email protected]

Facility Contacts

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Amy Harrigan

Role: primary

Other Identifiers

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19120

Identifier Type: -

Identifier Source: org_study_id