Back to resultsICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer (ISCAPE)
Primary Purpose
Colon Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
lymphatic mapping with indocyanine green
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Cancer focused on measuring colon cancer, lymphatic mapping, indocyanine green
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid)
- TNM T1-4a N0-2 M0-1
- Clinical indications to colonic resection
- ECOG - 0-2
- Signed informed consent.
Exclusion Criteria:
- Medical or psychiatric reasons interfering with patient's decision to participate in the study.
- Pregnancy or breastfeeding.
- Medical conditions contraindicating surgical procedure.
- Acute bowel obstruction, bleeding or perforation.
- Hypersensitivity to indocyanine green, sodium iodide or iodine
- Hyperthyroidism or autonomic thyroid adenomas
- Kidney failure of any aetiology
- Hepatic failure of any aetiology
- Poorly tolerated indocyanine injection in the past.
Sites / Locations
- N.N. Petrov National Medical Research Center of OncologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
interventional
Arm Description
lymphatic mapping by indocyanine green
Outcomes
Primary Outcome Measures
proportion of pN+ patients in which affected lymph nodes are detected only within margins of ICG distribution
number of patients with affected lymph nodes located within ICG distribution margins divided by the number of all patients with pN+
Secondary Outcome Measures
incidence of adverse events related to ICG lymphatic mapping
proportion of patients facing adverse events related to ICG lymphatic mapping procedure
feasibility of ICG lymphatic mapping for colon cancer
proportion of ICG spillage affecting interpretation
incidence of lymph node metastases outside conventional resection margins (10 cm)
proportion of patients with aberrant lymphatics leading to affected lymph nodes
colon cancer lymphatic spread pattern
descriptive data on incidence of D1, D2 and D3 lymphatic collector metastases and frequences of D1 collector metastases depending on distance from primary tumour
feasibility of ICG mapping for colon flexure tumours
proportion of operations for colon flexure tumours which extent is effected by ICG lymphatic mapping
Full Information
NCT ID
NCT05468827
First Posted
July 18, 2022
Last Updated
October 10, 2022
Sponsor
N.N. Petrov National Medical Research Center of Oncology
1. Study Identification
Unique Protocol Identification Number
NCT05468827
Brief Title
ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer
Acronym
ISCAPE
Official Title
ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
N.N. Petrov National Medical Research Center of Oncology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study is aimed at investigating feasibility of defining colon resection margins for colon cancer with ICG by comparing lymphatic distribution of subserosally injected dye with actual spread of lymphatic metastases reported by pathologists after specimen examination
Detailed Description
In this study 2.5 mg/ml indocyanine green solution is injected subserosally into colonic wall near the tumour in 4 points (1 ml each). The fluorescence is assessed before specimen removal (at least 30 min after injection) and its mesenteric distribution is marked by surgeon on the specimen. Proximal and distal colonic resection margins are chosen to be at least 10 cm long and to include the whole area of fluorescence. After removal, lymphatic node groups according JSCCR are also marked on fresh specimen. During pathological examination each lymph node is assessed not only for presence of metastases but also for its exact location in relation to margins of indocyanine distribution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
colon cancer, lymphatic mapping, indocyanine green
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all study participants are allocated to intraoperative ICG mapping of locoregional lymphatic collector
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interventional
Arm Type
Experimental
Arm Description
lymphatic mapping by indocyanine green
Intervention Type
Procedure
Intervention Name(s)
lymphatic mapping with indocyanine green
Intervention Description
subserosal injection of indocyanine green near the primary tumour with subsequent assessment of the dye spread along lymphatics
Primary Outcome Measure Information:
Title
proportion of pN+ patients in which affected lymph nodes are detected only within margins of ICG distribution
Description
number of patients with affected lymph nodes located within ICG distribution margins divided by the number of all patients with pN+
Time Frame
30 days
Secondary Outcome Measure Information:
Title
incidence of adverse events related to ICG lymphatic mapping
Description
proportion of patients facing adverse events related to ICG lymphatic mapping procedure
Time Frame
30 days
Title
feasibility of ICG lymphatic mapping for colon cancer
Description
proportion of ICG spillage affecting interpretation
Time Frame
duration of surgical procedure
Title
incidence of lymph node metastases outside conventional resection margins (10 cm)
Description
proportion of patients with aberrant lymphatics leading to affected lymph nodes
Time Frame
30 days
Title
colon cancer lymphatic spread pattern
Description
descriptive data on incidence of D1, D2 and D3 lymphatic collector metastases and frequences of D1 collector metastases depending on distance from primary tumour
Time Frame
30 days
Title
feasibility of ICG mapping for colon flexure tumours
Description
proportion of operations for colon flexure tumours which extent is effected by ICG lymphatic mapping
Time Frame
duration of surgical procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid)
TNM T1-4a N0-2 M0-1
Clinical indications to colonic resection
ECOG - 0-2
Signed informed consent.
Exclusion Criteria:
Medical or psychiatric reasons interfering with patient's decision to participate in the study.
Pregnancy or breastfeeding.
Medical conditions contraindicating surgical procedure.
Acute bowel obstruction, bleeding or perforation.
Hypersensitivity to indocyanine green, sodium iodide or iodine
Hyperthyroidism or autonomic thyroid adenomas
Kidney failure of any aetiology
Hepatic failure of any aetiology
Poorly tolerated indocyanine injection in the past.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lidiia Panaiotti, PhD
Phone
+79217892351
Email
panaiottilidiia@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksei Petrov, PhD
Phone
+79214117866
Email
alexpetrov@doctor.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksey Karachun, PhD
Organizational Affiliation
N.N. Petrov National Medicine Research Center of oncology
Official's Role
Study Director
Facility Information:
Facility Name
N.N. Petrov National Medical Research Center of Oncology
City
Saint Petersburg
ZIP/Postal Code
192289
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lidiia Panaiotti
Phone
+79217892351
Email
panaiottilidiia@gmail.com
First Name & Middle Initial & Last Name & Degree
Aleksei Petrov
Phone
+79214117866
Email
alexpetrov@doctor.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer
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