Sentinel Lymph Node Mapping and Analysis in Colon Cancer Using Indocyanine Green Dye

NCT04351009 | Completed DMC

• 1 other identifier: ICG001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 20-30 % of colon cancer patients who have no metastasis in lymph nodes after definitive colectomy have recurrence with distant metastasis. These recurrences could be due to missed occult tumor cells or micrometastasis. Detailed examination of all lymph nodes is expensive and time consuming. Sentinel lymph node mapping using Indocyanine green dye helps in identifying the lymph nodes which are most likely to harbour metastasis. These sentinel lymph nodes can be subsequently subjected to detailed pathologic examination and immunohistochemistry which increases the likelihood of identifying micrometastasis and occult tumor cells. Patients found to harbour such metastasis can be treated with additional chemotherapy after surgery. The aim of the study is to examine the feasibility of sentinel lymph node mapping using Indocyanine green dye in colon cancer and evaluate the upstaging rate in post-operative colon cancer patients who don't have metastatic lymph nodes on routine histopathology.

Conditions

Colon Cancer

Keywords

Sentinel lymph node; Indocyanine green

Outcome Measures

Primary Outcomes (2)

• Detection rate

  Proportion of the number of successful sentinel lymph node procedures out of all executed sentinel lymph node procedures.

  2 years

• Upstaging rate

  Sentinel lymph nodes in patients are pathologically node negative on routine evaluation with undergo detailed evaluation using serial sections and immunohistochemistry to identify micrometastasis and occult tumor cells. The proportion of node negative patients who are upstaged will be calculated.

  2 years

Secondary Outcomes (3)

• Accuracy

  2 years

• Negative predictive value

  2 years

• Aberrant lymph node drainage

  2 years

Study Arms (1)

Indocyanine green sentinel lymph node mapping

EXPERIMENTAL

Indocyanine green dye is injected in the submucosa or subserosa around the tumor to identify sentinel lymph nodes intra-operatively with near infrared fluorescence imaging.

Procedure: sentinel lymph node mapping

Interventions

sentinel lymph node mapping PROCEDURE

Through on-table colonoscopy indocyanine green solution will be injected in the submucosa at 2-4 points around the tumor for laparoscopic surgeries. Dye will be injected in the subserosa at 2-4 points for open surgeries. Lymphatic flow from the tumor will be mapped in real time with near-infrared fluorescence imaging scope and sentinel lymph nodes will be identified.

Indocyanine green sentinel lymph node mapping

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older Biopsy proven colon cancer Scheduled for laparoscopic/open colectomy

You may not qualify if:

• Prior colorectal surgery Gross lymph node invasion on pre-operative imaging or intraoperative staging Advanced disease (T4 disease or metastasis) on preoperative imaging or intraoperative staging Allergy to iodide containing compounds, human albumin or Indocyanine green dye History of hyperthyroidism or thyroid adenoma Palliative surgery Advanced hepatic failure Advanced renal failure

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Sanjeev M Patil, MS

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The pathologist involved in routine histological assessment of the resected lymph nodes including lymph nodes in the gross specimen and sentinel lymph nodes will be blinded to the identity of the sentinel lymph nodes.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sentinel lymph node mapping: 25 mg of Indocyanine green dye diluted in 1 ml of 20% Albumin solution and 9 ml of 0.9% Normal saline solution will be used. Injections (0.5-1 ml) will be given in the submucosa or subserosa at 2-4 points around the tumor proximally and distally. Lymphatic flow will be followed after injection in real time with Near-infrared fluorescence imaging scope until sentinel lymph nodes will be identified.

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 17, 2020
• Study Start: June 8, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)