Carbon Nanoparticles vs Indocyanine Green

A Multicentre Randomized Controlled Clinical Study of the Efficacy of Carbon Nanoparticles Versus Indocyanine Green in Surgical Treatment of Colorectal Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Number of Lymph Node Retrieved
• Intervention / Treatment: Drug: injecting Carbon Nanoparticles Suspension; Drug: Injecting indocyanine green

• Study Type: Interventional
• Enrollment (Anticipated): 298
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Xinxiang Li, MD; Phone Number: 86-21-64175590; Email: lxx1149@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Xinxiang Li, MD; Phone Number: 86-21-64175590; Email: lxx1149@163.com

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of lymph nodes detected	1 week after surgery
Number of positive lymph nodes detected at different T stages	1 week after surgery
the ratio of positive lymph nodes	1 week after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
patients' Disease-Free Survival(DFS)	1 year after surgery

Collaborators and Investigators

• Sponsor: LI XIN-XIANG

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: February 7, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CRC-SH02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No