Number of Lymph Node RetrievedPhase 2/3NCT04759820
Carbon Nanoparticles vs Indocyanine Green
A Phase 2/3 study testing injecting Carbon Nanoparticles Suspension and Injecting indocyanine green in people with Number of Lymph Node Retrieved, run by LI XIN-XIANG at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Number of Lymph Node Retrieved
- What is being tested?
- injecting Carbon Nanoparticles Suspension and Injecting indocyanine green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Jun 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
- Have a history of serious uncontrolled medical disease or recent myocardial infarction (within 3 months);Acute infection;
- Patients with uncontrolled severe hypertension and severe diabetes after intervention treatment;
- Allergic to the test drug;
- A history of alcohol, drug or substance abuse;
- Participants who had participated in any drug trial within 3 months prior to enrollment;
- Other subjects considered by the researcher to be unsuitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xinxiang Li, MD, 86-21-64175590, lxx1149@163.com
Renjie Wang, MD
About this study
Official title: 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.
- Conditions
- Number of Lymph Node Retrieved
- Being tested
- injecting Carbon Nanoparticles Suspension, Injecting indocyanine green
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injecting Carbon Nanoparticles SuspensionDrug
injecting Carbon Nanoparticles Suspension for lymph node detection
Injecting indocyanine greenDrug
Injecting indocyanine green for lymph node detection
| Study group | Role | What they receive |
|---|---|---|
| Nano carbon group | Experimental | Injection of carbon nanoparticle Receives: Drug: injecting Carbon Nanoparticles Suspension |
| Indocyanine green group | Active comparator | Injection of indocyanine green Receives: Drug: Injecting indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lymph nodes detected
Measured: 1 week after surgery
Number of positive lymph nodes detected at different T stages
Measured: 1 week after surgery
the ratio of positive lymph nodes
Measured: 1 week after surgery
Secondary outcomes (1)
patients' Disease-Free Survival(DFS)
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Number of Lymph Node RetrievedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LI XIN-XIANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LI XIN-XIANG, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759820
- Sponsor's protocol ID
- CRC-SH02
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Controlled Clinical Study of the Efficacy of Carbon Nanoparticles Versus Indocyanine Green in Surgical Treatment of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04759820
- Acronym / sponsor ID
- CRC-SH02
- Conditions
- Number of Lymph Node Retrieved
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- LI XIN-XIANGUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano carbon group | Experimental | Drug: injecting Carbon Nanoparticles SuspensionInjection of carbon nanoparticle |
| Indocyanine green group | Active comparator | Drug: Injecting indocyanine greenInjection of indocyanine green |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injecting Carbon Nanoparticles Suspensioninjecting Carbon Nanoparticles Suspension for lymph node detection | Drug | Nano carbon group |
| Injecting indocyanine greenInjecting indocyanine green for lymph node detection | Drug | Indocyanine green group |
Primary outcome
Number of lymph nodes detected
Time frame: 1 week after surgery
Number of positive lymph nodes detected at different T stages
Time frame: 1 week after surgery
the ratio of positive lymph nodes
Time frame: 1 week after surgery
1 secondary outcome
patients' Disease-Free Survival(DFS)
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing injecting Carbon Nanoparticles Suspension and Injecting indocyanine green in people with Number of Lymph Node Retrieved, run by LI XIN-XIANG at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinxiang Li, MD (86-21-64175590, lxx1149@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lymph nodes detected (time frame: 1 week after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.