A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients

NCT04591028 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 20-002747
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be looking at the safety and added benefit of using the Indocyanine green dye (ICG) during surgery.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• Positive ICG fluorescence lymph nodes

  Total number of lymph nodes removed after surgery that are positive for ICG fluorescence

  Approximately 30-90 days after surgery

• Disease positive lymph nodes

  Number of ICG positive lymph nodes that are also positive for disease

  Approximately 30-90 days after surgery

• Number of lymph nodes removed for each lymphatic station of gastrectomy

  Total number of lymph nodes removed for each lymphatic station of gastrectomy with NIR+ICG vs gastrectomy without NIR+ICG

  Approximately 30-90 days after surgery

Study Arms (1)

Intervention

OTHER

Injection of Indocyamine Green.

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

A one time injection of IDC prior to the day of scheduled surgery.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 and ≤ 75 years of age.
• Primary gastric adenocarcinoma of any histological subtype confirmed pathologically by endoscopic biopsy.
• Clinical stage tumor T1-4a (cT1-4a), N -/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
• No distant metastasis, no direct invasion of adjacent organs such as pancreas and spleen in preoperative exams.
• American Society of Anesthesiology score (ASA) class I, II, or III.
• Written informed consent.

You may not qualify if:

• Patients ≤ 18 and ≥ 75 years of age.
• History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
• History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection.
• History of allergy to iodine agents.
• History of other malignant disease within past five years.
• Emergency surgery due to complication caused by gastric cancer, such as bleeding obstruction or perforation.
• Patients intraoperatively/postoperatively confirmed as T4b.
• Patients intraoperatively confirmed as unable to complete D2 lymph node dissection or R0 dissection.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Enrique F Elli, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 19, 2020
• Study Start: January 1, 2022
• Primary Completion: January 1, 2022
• Study Completion: August 10, 2022
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)