Sentinel Node Mapping With Indocyanine Green in Colon Cancer: a Feasibility Trial and a Descriptive Serie.
SENSE
1 other identifier
interventional
30
1 country
1
Brief Summary
This study is a clinical feasibility trial that will contribute to the clarification of whether sentinel node mapping with indocyanine green (ICG) provides a better basis for staging of colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 17, 2016
February 1, 2016
11 months
June 6, 2014
February 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of procedures with successful identification of sentinel nodes
Sentinel nodes is defined as the lymph node, first in line, draining from the cancer.
day 1
Secondary Outcomes (13)
Number of sentinel nodes identified during surgery and their localization
day 1
Number of sentinel nodes identified by ex vivo sentinel node mapping
week 1
Malignant status of the sentinel node(s)
week 1
Malignant status of the lymph nodes
week 1
Number of cases with negative sentinel node, but positive non-sentinel node
week 1
- +8 more secondary outcomes
Study Arms (1)
Sentinel node mapping
EXPERIMENTALSentinel node mapping with indocyanine green injected orally and anally to the tumor.
Interventions
Through transabdominal access via laparoscopic ports indocyanine green solution is injected around the tumor (25 mg indocyanine green dissolved in 9 ml sterile water and 1 ml 20% human albumin). This is done by the construction of two small boluses of 0.5 mL each into the colonic wall just orally and anally to the tumor margin, but not within the tumor itself. When the bolus is injected the fluorescence is controlled and after 20 minutes the surgeon looks for sentinel nodes in a standardized manner.
Eligibility Criteria
You may qualify if:
- Male and female patients above 18 years of age scheduled for laparoscopic colon cancer surgery in the department of Surgery, Herlev Hospital or Roskilde Hospital.
You may not qualify if:
- iodine allergy
- Poor kidney function (as it imply an increased risk of allergic reaction), estimated glomerular filtration rate should be above 40 ml/min.
- Liver cirrhosis, Child-Pugh-score B and C \[14\]
- Pregnancy and lactation
- Previous anaphylactic reaction to a dye injection
- Previous abdominal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ismail Gögenürlead
Study Sites (1)
Herlev Hospital
Herlev, Herlev, 2730, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ismail Gögenur, Professor
Professor at University Hospital Køge
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, DMSc, MD
Study Record Dates
First Submitted
June 6, 2014
First Posted
June 18, 2014
Study Start
March 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
February 17, 2016
Record last verified: 2016-02