- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04591028
A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients
July 17, 2023 updated by: Enrique F. Elli, Mayo Clinic
Indocyanine Green Lymphangiography as a Tool for Improving Lymphadenectomy in Gastric Cancer
This study will be looking at the safety and added benefit of using the Indocyanine green dye (ICG) during surgery.
Study Overview
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic in Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
Injection of Indocyamine Green.
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A one time injection of IDC prior to the day of scheduled surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive ICG fluorescence lymph nodes
Time Frame: Approximately 30-90 days after surgery
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Total number of lymph nodes removed after surgery that are positive for ICG fluorescence
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Approximately 30-90 days after surgery
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Disease positive lymph nodes
Time Frame: Approximately 30-90 days after surgery
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Number of ICG positive lymph nodes that are also positive for disease
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Approximately 30-90 days after surgery
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Number of lymph nodes removed for each lymphatic station of gastrectomy
Time Frame: Approximately 30-90 days after surgery
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Total number of lymph nodes removed for each lymphatic station of gastrectomy with NIR+ICG vs gastrectomy without NIR+ICG
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Approximately 30-90 days after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Enrique F Elli, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2022
Primary Completion (Estimated)
January 1, 2022
Study Completion (Estimated)
August 10, 2022
Study Registration Dates
First Submitted
October 15, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
July 19, 2023
Last Update Submitted That Met QC Criteria
July 17, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-002747
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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City of Hope Medical CenterRecruitingGastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion | Gastric Cancer in Situ | Gastric Cancer Stage IIIB | Gastric... and other conditionsUnited States, Japan
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City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage 0 Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage II Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric Cancer AJCC v8 | Pathologic Stage... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedGastric Adenocarcinoma | Stage IV Gastric Cancer | Stage II Gastric Cancer | Stage III Gastric CancerUnited States
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Clinical Trials on Indocyanine green
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University of PennsylvaniaCompletedIschemic Stroke | Traumatic Brain Injury | Subarachnoid Hemorrhage | Intracerebral Hemorrhage | Acute Anoxic EncephalopathyUnited States
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Corporacion Parc TauliRecruitingAcute Cholecystitis | Bile Duct InjurySpain
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Wei ChenEnrolling by invitation
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Shanghai University of Traditional Chinese MedicineUnknownRheumatoid Arthritis | Lymph Node Mass | Lymphatic Vessel; DilatationChina
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Memorial Sloan Kettering Cancer CenterActive, not recruitingOvarian Cancer | Adnexal MassUnited States
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Birmingham Women's and Children's NHS Foundation...Not yet recruitingTracheo-Esophageal Fistula With Atresia of EsophagusUnited Kingdom
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Bakirkoy Dr. Sadi Konuk Research and Training HospitalRecruitingSentinel Lymph NodeTurkey
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NYU Langone HealthRecruitingRotator Cuff TearsUnited States
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Rigshospitalet, DenmarkTerminatedGastric CancerDenmark
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Institut de Cancérologie de LorraineCompleted