Carbon Nanoparticles vs Indocyanine Green

NCT04759820 | Unknown Phase 2

• 1 other identifier: CRC-SH02
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

Number of Lymph Node Retrieved

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• patients' Disease-Free Survival(DFS)

  1 year after surgery

Study Arms (2)

Nano carbon group

EXPERIMENTAL

Injection of carbon nanoparticle

Drug: injecting Carbon Nanoparticles Suspension

Indocyanine green group

ACTIVE COMPARATOR

Injection of indocyanine green

Drug: Injecting indocyanine green

Interventions

injecting Carbon Nanoparticles Suspension DRUG

injecting Carbon Nanoparticles Suspension for lymph node detection

Nano carbon group

Injecting indocyanine green DRUG

Injecting indocyanine green for lymph node detection

Indocyanine green group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Colorectal cancer was confirmed by preoperative fibrocolonoscopy and pathological examination;
• 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;
• The lower edge of the lesion is located more than 10cm from the anus;
• Age 18 \~ 70;
• 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.
• Patients had no psychological, family, social, or geographical constraints that affected protocol compliance and follow-up time
• Patient signs informed consent;

You may not qualify if:

• Under 18 years old or above 70 years old;
• Other types of colorectal cancer (adenosquamous cell carcinoma, squamous cell carcinoma, neuroendocrine tumor, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma)
• Rectum cancer less than 10cm from the anus;
• Previous abdominal surgery;
• Neoadjuvant therapy was received preoperatively, including radiotherapy and chemotherapy;
• Due to various reasons, preoperative colonoscopic injection of carbon nanoparticles/indocyanine green labeling was not possible;
• Intraoperative radical surgery cannot be performed due to various reasons;
• Acute abdomen: intestinal obstruction, intestinal wringing, peritonitis, etc.;
• Combined with other site metastasis;
• Have severe heart, lung, liver and kidney diseases and cannot tolerate surgery;
• Active stage of liver disease or abnormal liver function, ALT, AST, TBIL more than twice the upper limit of normal value;
• Renal function impairment, Cr≥2 times the upper limit of normal or BUN≥2 times the upper limit of normal;
• 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;
• People with mental illness or mental retardation who cannot describe their feelings correctly;
• Severe disorder of coagulation mechanism and bleeding tendency;

Sponsors & Collaborators

• LI XIN-XIANG: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Xinxiang Li, MD

CONTACT

86-21-64175590; lxx1149@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 18, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

CN (1)