Stomach NeoplasmNCT04056260
ICG-NIR Guided Lymph Node Dissection in Gastric Cancer
A study testing ICG-NIR guided surgery in people with Stomach Neoplasm, run by Ho Seok Seo.
Trial summary
As the survival rate of patients with gastric cancer has increased, there has been a growing interest in interventions that improve postoperative quality of life. Therefore minimally invasive surgery or endoscopic resection has been performed much more frequently. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stomach Neoplasm
- What is being tested?
- ICG-NIR guided surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2020to 31 Dec 2020
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dignosed gastric adenocarcinoma
- tumor: size 4cm or smaller
- depth of invasion: mucosa, submucosa, proper muscle
- candidates of laparoscopic radical gastrectomy
- informed consent
Who cannot join
- metachronous malignancy
- number of tumors: 2 or more
- remnant gastric cancer
- indication for endoscopic resection
- history of chemotherapy or radiation therapy
- pregnancy
- allergy to ICG
- metastatic gastric cancer
About this study
Official title: Oncologic Safety of Sentinel Lymph Node-guided Lymph Node Dissection Using ICG-NIR Laparoscopy in Gastric Cancer
As the survival rate of patients with gastric cancer has increased, there has been a growing interest in interventions that improve postoperative quality of life. Therefore minimally invasive surgery or endoscopic resection has been performed much more frequently. However, adequate lymph node dissection is important as well. The aim of the study is to identify the feasibility of indocyanine green - near infra-red (ICG-NIR) guided sentinel lymph node dissection for the treatment of gastric cancer.
- Conditions
- Stomach Neoplasm
- Being tested
- ICG-NIR guided surgery
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-NIR guided surgeryProcedure or surgery
ICG 0.5mg/ml x 0.5ml x 4 sites injection through intra-operative endoscopy
| Study group | Role | What they receive |
|---|---|---|
| ICG injection | Experimental | ICG 0.5mg/ml x 0.5ml x 4 sites Receives: Procedure: ICG-NIR guided surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity
sensitivity and specificity of ICG-NIR guided lymph node dissection
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start20 Mar 2020 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ho Seok Seo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ho Seok Seo, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056260
- Sponsor's protocol ID
- SDR-01
- Status last verified
- Mar 2020
- First submitted
- 11 Aug 2019
- Last updated
- 20 Mar 2020
- 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 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncologic Safety of Sentinel Lymph Node-guided Lymph Node Dissection Using ICG-NIR Laparoscopy in Gastric Cancer
- ClinicalTrials.gov ID
- NCT04056260
- Acronym / sponsor ID
- SDR-01
- Conditions
- Stomach Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- Ho Seok SeoUniversity, hospital or other
- Study start
- 20 Mar 2020 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Aug 2019 (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.
As the survival rate of patients with gastric cancer has increased, there has been a growing interest in interventions that improve postoperative quality of life. Therefore minimally invasive surgery or endoscopic resection has been performed much more frequently. However, adequate lymph node dissection is important as well. The aim of the study is to identify the feasibility of indocyanine green - near infra-red (ICG-NIR) guided sentinel lymph node dissection for the treatment of gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG injection | Experimental | Procedure: ICG-NIR guided surgeryICG 0.5mg/ml x 0.5ml x 4 sites |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- dignosed gastric adenocarcinoma
- tumor: size 4cm or smaller
- depth of invasion: mucosa, submucosa, proper muscle
- candidates of laparoscopic radical gastrectomy
- informed consent
Key exclusion criteria (8 listed)
- metachronous malignancy
- number of tumors: 2 or more
- remnant gastric cancer
- indication for endoscopic resection
- history of chemotherapy or radiation therapy
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 |
|---|---|---|
| ICG-NIR guided surgeryICG 0.5mg/ml x 0.5ml x 4 sites injection through intra-operative endoscopy | Procedure or surgery | ICG injection |
Primary outcome
sensitivity and specificity
Time frame: 1 month
sensitivity and specificity of ICG-NIR guided lymph node dissection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ICG-NIR guided surgery in people with Stomach Neoplasm, run by Ho Seok Seo.
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 5 inclusion and 8 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 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
sensitivity and specificity (time frame: 1 month). 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 20 Mar 2020.