ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer

Colon Cancer Clinical Trial

— ISCAPE  

Official title:

ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05468827
• Other study ID #: ISC-1
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: July 2024

Study information

• Verified date: July 2022
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: Lidiia Panaiotti, PhD
• Phone: +79217892351
• Email: panaiottilidiia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid)

2. TNM T1-4a N0-2 M0-1

3. Clinical indications to colonic resection

4. ECOG - 0-2

5. Signed informed consent.

Exclusion Criteria:

1. Medical or psychiatric reasons interfering with patient's decision to participate in the study.

2. Pregnancy or breastfeeding.

3. Medical conditions contraindicating surgical procedure.

4. Acute bowel obstruction, bleeding or perforation.

5. Hypersensitivity to indocyanine green, sodium iodide or iodine

6. Hyperthyroidism or autonomic thyroid adenomas

7. Kidney failure of any aetiology

8. Hepatic failure of any aetiology

9. Poorly tolerated indocyanine injection in the past.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Procedure:
• lymphatic mapping with indocyanine green
subserosal injection of indocyanine green near the primary tumour with subsequent assessment of the dye spread along lymphatics

Locations

Country	Name	City	State
Russian Federation	N.N. Petrov National Medical Research Center of Oncology	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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+	30 days
Secondary	incidence of adverse events related to ICG lymphatic mapping	proportion of patients facing adverse events related to ICG lymphatic mapping procedure	30 days
Secondary	feasibility of ICG lymphatic mapping for colon cancer	proportion of ICG spillage affecting interpretation	duration of surgical procedure
Secondary	incidence of lymph node metastases outside conventional resection margins (10 cm)	proportion of patients with aberrant lymphatics leading to affected lymph nodes	30 days
Secondary	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	30 days
Secondary	feasibility of ICG mapping for colon flexure tumours	proportion of operations for colon flexure tumours which extent is effected by ICG lymphatic mapping	duration of surgical procedure