Carbon Nanoparticles vs Indocyanine Green

• ClinicalTrials.gov Identifier: NCT04759820
• Recruitment Status: Recruiting
• First Posted: February 18, 2021
• Last Update Posted: February 18, 2021
• Sponsor: LI XIN-XIANG
• Information provided by (Responsible Party): LI XIN-XIANG, Fudan University

Study Description

Brief Summary:

Both nano carbon and ICG as lymph node tracers in colorectal cancer have their own value, this study was to contrast two tracers in colorectal cancer surgeries, so as to find out the best lymphnode tracer in colorectal cancer, in order to further improve postoperative lymph node inspection, precise postoperative adjuvant therapy and improve the patients' long-term survival.

Condition or disease	Intervention/treatment	Phase
Number of Lymph Node Retrieved	Drug: injecting Carbon Nanoparticles Suspension; Drug: Injecting indocyanine green	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 298 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Multicentre Randomized Controlled Clinical Study of the Efficacy of Carbon Nanoparticles Versus Indocyanine Green in Surgical Treatment of Colorectal Cancer
• Actual Study Start Date: January 1, 2021
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: June 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nano carbon group; Injection of carbon nanoparticle	Drug: injecting Carbon Nanoparticles Suspension; injecting Carbon Nanoparticles Suspension for lymph node detection
Active Comparator: Indocyanine green group; Injection of indocyanine green	Drug: Injecting indocyanine green; Injecting indocyanine green for lymph node detection

Outcome Measures

Primary Outcome Measures :

1. Number of lymph nodes detected [ Time Frame: 1 week after surgery ]
2. Number of positive lymph nodes detected at different T stages [ Time Frame: 1 week after surgery ]
3. the ratio of positive lymph nodes [ Time Frame: 1 week after surgery ]

Secondary Outcome Measures :

1. patients' Disease-Free Survival(DFS) [ Time Frame: 1 year after surgery ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Colorectal cancer was confirmed by preoperative fibrocolonoscopy and pathological examination;
2. The operative requirements of the patients included in the study: laparoscopic radical surgery of colon/rectal cancer, indocyanine green group should be used fluorescent laparoscopic (Pinpoint) surgery;
3. The lower edge of the lesion is located more than 10cm from the anus;
4. Age 18 ~ 70;
5. The results of laboratory examination before enrollment met the following surgical conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥ 100×109/L, total bilirubin (TBI) ≤1.5× upper limit of normal (2mg/ dL), alanine aminotransferase (ALT), ascarate aminotransferase (AST) ≤2× upper limit of normal;The coagulation parameters were in the normal range.
6. Patients had no psychological, family, social, or geographical constraints that affected protocol compliance and follow-up time
7. Patient signs informed consent;

Exclusion Criteria:

1. Under 18 years old or above 70 years old;
2. Other types of colorectal cancer (adenosquamous cell carcinoma, squamous cell carcinoma, neuroendocrine tumor, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma)
3. Rectum cancer less than 10cm from the anus;
4. Previous abdominal surgery;
5. Neoadjuvant therapy was received preoperatively, including radiotherapy and chemotherapy;
6. Due to various reasons, preoperative colonoscopic injection of carbon nanoparticles/indocyanine green labeling was not possible;
7. Intraoperative radical surgery cannot be performed due to various reasons;
8. Acute abdomen: intestinal obstruction, intestinal wringing, peritonitis, etc.;
9. Combined with other site metastasis;
10. Have severe heart, lung, liver and kidney diseases and cannot tolerate surgery;
11. Active stage of liver disease or abnormal liver function, ALT, AST, TBIL more than twice the upper limit of normal value;
12. Renal function impairment, Cr≥2 times the upper limit of normal or BUN≥2 times the upper limit of normal;
13. The subjects' white blood cells are lower than the lower limit of normal value, or their platelets are lower than the lower limit of normal value, or have other diseases of the blood system;
14. People with mental illness or mental retardation who cannot describe their feelings correctly;
15. Severe disorder of coagulation mechanism and bleeding tendency;
16. Have a history of serious uncontrolled medical disease or recent myocardial infarction (within 3 months);Acute infection;
17. Patients with uncontrolled severe hypertension and severe diabetes after intervention treatment;
18. Allergic to the test drug;
19. A history of alcohol, drug or substance abuse;
20. Participants who had participated in any drug trial within 3 months prior to enrollment;
21. Other subjects considered by the researcher to be unsuitable for inclusion in this study.

Contacts and Locations

Contacts

Contact: Xinxiang Li, MD; 86-21-64175590; lxx1149@163.com

Locations

China, Shanghai

Fudan University Shanghai Cancer Center; Recruiting

Shanghai, Shanghai, China, 200032

Contact: Xinxiang Li, MD 86-21-64175590 lxx1149@163.com

Sub-Investigator: Renjie Wang, MD

Sponsors and Collaborators

LI XIN-XIANG

More Information

• Responsible Party: LI XIN-XIANG, Professor, Fudan University
• ClinicalTrials.gov Identifier: NCT04759820
• Other Study ID Numbers: CRC-SH02
• First Posted: February 18, 2021
• Last Update Posted: February 18, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No