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Gastric CancerPhase 2FUTURE-01NCT05229874

Effect of CNSI vs. ICG in Lymph Node Tracing During Gastrectomy

A Phase 2 study testing carbon nanoparticles and Indocyanine green in people with Gastric Cancer, run by Hebei Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the efficacy and safety of carbon nanoparticle suspension injection and indocyanine green tracer-guided lymph node dissection during gastrectomy in patients with gastric cancer Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
carbon nanoparticles and Indocyanine green
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteChina
Study dates
20 Jan 2022to 20 Jan 2025
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age from 18 to 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  • American Society of Anesthesiology score (ASA) class I, II, or III
  • Written informed consent

Who cannot join

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  • Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  • History of other malignant disease within past five years
Show all 14Show fewer
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1<50% of predicted values
  • Diffuse; widespread; plastica

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fourth Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

Other trials in China

About this study

Official title: A Prospective Randomized Controlled Study of the Efficacy of Carbon Nanoparticles Versus Indocyanine Green in Robotic or Laparoscopic Gastrectomy

The purpose of this study is to assess the efficacy and safety of carbon nanoparticle suspension injection and indocyanine green tracer-guided lymph node dissection during gastrectomy in patients with gastric cancer

Read the detailed description

Da Vinci robot surgery XI system has fluorescence imaging function, which can realize indocyanine green lymph node tracking navigation technology in the operation. At the same time, the lymph node tracking effect of nano carbon suspension injection is not affected by equipment. The flexible mechanical arm of Da Vinci robot combined with the application of lymph node tracing technology makes the lymph node dissection of gastric cancer surgery more thorough, and also reduces the difficulty of surgery. Indocyanine green navigational lymphadenectomy can also be performed by fluorescence laparoscopy. By comparing the two tracer techniques, the lymph node tracer technique which is more suitable for robot or laparoscopic surgery system is selected to provide help and choice for clinical surgeons.

Conditions
Gastric Cancer
Being tested
carbon nanoparticles, Indocyanine green
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carbon nanoparticlesDrug

    Also called carbon nanoparticle suspension injection

    Endoscopic injection

  • Indocyanine greenDrug

    Also called ICG

    Endoscopic injection

Study groups in NCT05229874
Study groupRoleWhat they receive
Carbon nanoparticle suspension injection (CNSI) groupExperimentalCNSI (50 mg/dose) was produced by Chongqing Lesmei Pharmaceutical Co., Ltd.: Carbon nanoparticles were marked in the endoscopy division 1 day before surgery, and CNSI was injected submucosally at 4 points (proximal side, distal side, and left and right sides) 0.5-1 cm from the tumor edge under endoscopy. The test dose for each point was approximately 0.25 ml.
Receives: Drug: carbon nanoparticles
Indocyanine green (ICG) groupActive comparatorICG (25 mg/dose) was produced by Dandong Yichuang Pharmaceutical. ICG was marked in the endoscopy division 1 day before surgery and injected submucosally at 4 points (proximal side, distal side, and left and right sides) 0.5-1 cm from the tumor edge under endoscopy. The test dose for each point was approximately 0.5 ml. Both procedures were performed by a designated medical practitioner.
Receives: Drug: Indocyanine green

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Number of Retrieved Lymph Nodes

    Compare total number of retrieved lymph nodes in both group.

    Measured: 10 days

Secondary outcomes (11)

  1. The rate of black-stained/fluorescence

    The number of black-stained/fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group

    Measured: 10 days

  2. Positive rate

    The number of positive lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group

    Measured: 10 days

  3. False positive rate

    The number of negative lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group

    Measured: 10 days

  4. Negative rate

    The number of negative lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group

    Measured: 10 days

  5. False negative rate

    The number of positive lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group

    Measured: 10 days

  6. Number of Metastasis Lymph Nodes

    Compare number of positive lymph nodes in both group.

    Measured: 10 days

  7. Morbidity and mortality rates

    This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.

    Measured: 30 days

  8. 3-year disease free survival rate

    Disease-free survival is calculated from the day of surgery to the day of recurrence (When the specific date of recurrence of the tumor is unknown, the ending point is the date of death due to tumor causes). In the event that neither death nor recurrence of the tumor are observed, the end point is the final date that a patient is confirmed as relapse-free.

    Measured: 36 months

  9. 3-year recurrence pattern

    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

    Measured: 36 months

  10. Intraoperative blood loss

    Intraoperative blood loss

    Measured: 1 day

  11. Postoperative lymph node anatomy duration

    Postoperative lymph node anatomy duration

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start20 Jan 2022
  3. Primary completion9 Mar 2023
  4. Study completion20 Jan 2025 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05229874
Sponsor's protocol ID
FUTURE-01
Acronym
FUTURE-01
Status last verified
Oct 2023
First submitted
15 Jan 2022
Last updated
19 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tian Y, Pang Y, Yang P, Guo S, Ma W, Guo H, Liu Y, Zhang Z, Ding P, Zheng T, Li Y, Fan L, Zhang Z, Wang D, Zhao X, Tan B, Liu Y, Zhao Q. Effect of carbon nanoparticle suspension injection versus indocyanine green tracer in guiding lymph node dissection during radical gastrectomy (FUTURE-01): a randomized clinical trial. Int J Surg. 2025 Jan 1;111(1):609-616. doi: 10.1097/JS9.0000000000001873.

    PubMed 38954670

  • Tian Y, Pang Y, Yang P, Guo H, Liu Y, Zhang Z, Ding P, Zheng T, Li Y, Fan L, Zhang Z, Zhao X, Tan B, Wang D, Zhao Q. The safety and efficacy of carbon nanoparticle suspension injection versus indocyanine green tracer-guided lymph node dissection during radical gastrectomy (FUTURE-01): A single-center randomized controlled trial protocol. Front Oncol. 2023 Jan 6;12:1044854. doi: 10.3389/fonc.2022.1044854. eCollection 2022.

    PubMed 36686792

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carbon nanoparticles and Indocyanine green in people with Gastric Cancer, run by Hebei Medical University 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 14 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 19 Oct 2023. 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 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Retrieved Lymph Nodes (time frame: 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05229874, which also lists 2 linked publications.

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 19 Oct 2023.

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FUTURE-01 Clinical Trial NCT05229874 | AzTrials