Early Gastric CancerNCT02710838
The Feasible Research of Infrared Endoscope to Diagnose Early Gastric Cancer
A study testing infrared endoscopy in people with Early Gastric Cancer, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
The gastric cancer is the second most frequently diagnosed cancer and the third leading cause of cancer death in China.80%-90% patients were detected at middle and later stage.The five-year survival rate for advanced gastric cancer patients is less than 10% due to the shortage of effective treatment method.The… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- infrared endoscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Feb 2017
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age：18-70
- Sex：unlimited；
- Group 1：patients with EGC，willing to receive treatment under endoscopy（EMR/ESD）
- Group 2：patients for screening，or have some general symptoms dyspepsia、epigastric pain）who need to be examined by endoscopy
- Informed consent issued
Who cannot join
- Severe liver and kidney disease;
- Iodine, seafood or other severe allergies history；
- Patients with severe heart or pulmonary disease which is not suitable for endoscopic examination
- Higher blood risk of esophageal varices
- Pregnant or lactating female
- Without patient's consent
- The investigator considers other condition which is not suitable for participation
Trial locations and contacts
1 site in 1 country.
Lu Niu contact
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Shuhui Liang, M.D., 86-13572885507, liangsh@fmmu.edu.cn
Lu Niu, 710257073@qq.com
About this study
Official title: The Feasible Research of Infrared Endoscope to Diagnose Early Gastric Cancer and Evaluate the Invasive Depth of Tumors
The gastric cancer is the second most frequently diagnosed cancer and the third leading cause of cancer death in China.80%-90% patients were detected at middle and later stage.The five-year survival rate for advanced gastric cancer patients is less than 10% due to the shortage of effective treatment method.The five-year survival rate for early gastric cancer patients is beyond 90%.The reason for poor diagnosis and treatment is that current methods do not achieve the diagnosis of early gastric cancer.Endoscopy with biopsy is still the main method for confirming gastric cancer.But it is limited to identify early gastric cancer and it leads to the low diagnostic rate of early gastric cancer.
Infrared endoscopic imaging is a new great potential method of diagnosis of early gastric cancer, since the first report in the 1990s, people have been exploring in this field. Through intravenous injection of exogenous contrast medium, such as the indocyanine green, it makes mucosal lesions highlight,and avoids the interference of background light.If specific target molecular is linked to the contrast medium,the specific imaging of the lesion can be presented. What is more,due to the strong penetration power of infrared light,its imaging depth also increases significantly.Indocyanine green had also been demonstrated safe in clinical studies and widely used. On this basis,we apply for the research about near-infrared endoscopy to diagnose early gastric cancer,and discuss its feasibility of the infrared endoscopy to diagnose early gastric cancer and clinical value.
Read the detailed description
The gastric cancer is the second most frequently diagnosed cancer and the third leading cause of cancer death in China.80%-90% patients were detected at middle and later stage.The five-year survival rate for advanced gastric cancer patients is less than 10% due to the shortage of effective treatment method.The five-year survival rate for early gastric cancer patients is beyond 90%.The reason for poor diagnosis and treatment is that current methods do not achieve the diagnosis of early gastric cancer.Endoscopy with biopsy is still the main method for confirming gastric cancer.But it is limited to identify early gastric cancer and it leads to the low diagnostic rate of early gastric cancer.
Accurate diagnosis for early gastric cancer and the pretherapeutic estimation of the invasion depth is desired to determine suitable treatment.Presently,endoscopic submucosal dissection is the new effective minimally invasive treatment for early gastric cancer,which preserve the entire stomach and improve the patient's postoperative quality of life.But the estimation of invasion depth of gastric cancers should be confirmed before operation.
Recently,some research suggest that narrow banding imaging and endoscopy ultrasonography are considered established means of diagnosis for early gastric cancer and depth.No formal quantitative review of the available evidence has been published that narrow banding imaging or endoscopy ultrasonography could accurately diagnose early gastric cancer and evaluate the invasive depth.This means still has great limitations.The sensitivity of narrow banding imaging diagnosis is only 60% which its high false positive rate,shorter wavelength and lighter penetration,and the result is influenced by histologic variety of early gastric cancer and inflammatory changes in the background mucosa;Although endoscopy ultrasonography achieves a diagnostic accuracy of over 80%,and its tomographic views facilitate objective assessments,it is occasionally difficult to obtain images with adequate quality, and its evaluation is highly dependent on operators' proficiency levels.
Infrared endoscopic imaging is a new great potential method of diagnosis of early gastric cancer, since the first report in the 1990 s, people have been exploring in this field. Through intravenous injection of exogenous contrast medium, such as the indocyanine green, it makes mucosal lesions highlight,and avoids the interference of background light.If specific target molecular is linked to the contrast medium,the specific imaging of the lesion can be presented. What is more,due to the strong penetration power of infrared light,its imaging depth also increases significantly.Indocyanine green had also been demonstrated safe in clinical studies and widely used, such assessment of liver function tests.
At present,the research in this aspect is very few, a few clinical research results show that infrared endoscopic imaging has a larger value for differentiating between early gastric cancer and gastric adenoma, and the difference between early gastric cancer and gastric lesions is significantly correlated with the depth of cancer invasion.
However, there is not a system research about the infrared imaging characteristics of gastric cancer and different precancerous status,and there is no infrared endoscopic imaging assessment criteria for diagnosis of gastric cancer.
Recently, the investigators have completed the experiments on animals about infrared imaging, the results prove that it has good specificity to identify tumor lesion. On this basis,the investigators apply for the research about near-infrared endoscopy to diagnose early gastric cancer,and discuss its feasibility of the infrared endoscopy to diagnose early gastric cancer and clinical value.
- Conditions
- Early Gastric Cancer
- Being tested
- infrared endoscopy
- Keywords
- Early gastric cancer, Infrared endoscope
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infrared endoscopyDevice
Firstly use standard white light and narrow-band imaging to observe the lesion, and then inject the contrast medium ICG, after 2 minutes,switch to infrared light to observe, record the image data, then accomplish the examination.
| Study group | Role | What they receive |
|---|---|---|
| Cancer group | Experimental | All patients receive the infrared endoscopy after injecting indocyanine green（ICG） intravenously. Receives: Device: infrared endoscopy |
| Non-cancer group | Other | All patients receive the infrared endoscopy after injecting ICG intravenously. Receives: Device: infrared endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the lesion of early gastric cancer by infrared endoscopy
confirming that the lesion of early gastric cancer can gather indocyanine green and can be observed by the infrared endoscopy.
Measured: up to two years
Secondary outcomes (1)
the invasive depth of early gastric cancer by infrared endoscopy
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJan 2014
- Primary completionJun 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuhui Liang, Xijing Hospital of Digestive Diseases
- Investigators
- Kaichun Wu, M.D., Prof., Study director, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710838
- Sponsor's protocol ID
- IRI-EGC
- Status last verified
- Mar 2016
- First submitted
- 29 Feb 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasible Research of Infrared Endoscope to Diagnose Early Gastric Cancer and Evaluate the Invasive Depth of Tumors
- ClinicalTrials.gov ID
- NCT02710838
- Acronym / sponsor ID
- IRI-EGC
- Conditions
- Early Gastric Cancer
- Keywords
- Early gastric cancer, Infrared endoscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- 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.
The gastric cancer is the second most frequently diagnosed cancer and the third leading cause of cancer death in China.80%-90% patients were detected at middle and later stage.The five-year survival rate for advanced gastric cancer patients is less than 10% due to the shortage of effective treatment method.The five-year survival rate for early gastric cancer patients is beyond 90%.The reason for poor diagnosis and treatment is that current methods do not achieve the diagnosis of early gastric cancer.Endoscopy with biopsy is still the main method for confirming gastric cancer.But it is limited to identify early gastric cancer and it leads to the low diagnostic rate of early gastric cancer.
Infrared endoscopic imaging is a new great potential method of diagnosis of early gastric cancer, since the first report in the 1990s, people have been exploring in this field. Through intravenous injection of exogenous contrast medium, such as the indocyanine green, it makes mucosal lesions highlight,and avoids the interference of background light.If specific target molecular is linked to the contrast medium,the specific imaging of the lesion can be presented. What is more,due to the strong penetration power of infrared light,its imaging depth also increases significantly.Indocyanine green had also been demonstrated safe in clinical studies and widely used. On this basis,we apply for the research about near-infrared endoscopy to diagnose early gastric cancer,and discuss its feasibility of the infrared endoscopy to diagnose early gastric cancer and clinical value.
Detailed description
The gastric cancer is the second most frequently diagnosed cancer and the third leading cause of cancer death in China.80%-90% patients were detected at middle and later stage.The five-year survival rate for advanced gastric cancer patients is less than 10% due to the shortage of effective treatment method.The five-year survival rate for early gastric cancer patients is beyond 90%.The reason for poor diagnosis and treatment is that current methods do not achieve the diagnosis of early gastric cancer.Endoscopy with biopsy is still the main method for confirming gastric cancer.But it is limited to identify early gastric cancer and it leads to the low diagnostic rate of early gastric cancer.
Accurate diagnosis for early gastric cancer and the pretherapeutic estimation of the invasion depth is desired to determine suitable treatment.Presently,endoscopic submucosal dissection is the new effective minimally invasive treatment for early gastric cancer,which preserve the entire stomach and improve the patient's postoperative quality of life.But the estimation of invasion depth of gastric cancers should be confirmed before operation.
Recently,some research suggest that narrow banding imaging and endoscopy ultrasonography are considered established means of diagnosis for early gastric cancer and depth.No formal quantitative review of the available evidence has been published that narrow banding imaging or endoscopy ultrasonography could accurately diagnose early gastric cancer and evaluate the invasive depth.This means still has great limitations.The sensitivity of narrow banding imaging diagnosis is only 60% which its high false positive rate,shorter wavelength and lighter penetration,and the result is influenced by histologic variety of early gastric cancer and inflammatory changes in the background mucosa;Although endoscopy ultrasonography achieves a diagnostic accuracy of over 80%,and its tomographic views facilitate objective assessments,it is occasionally difficult to obtain images with adequate quality, and its evaluation is highly dependent on operators' proficiency levels.
Infrared endoscopic imaging is a new great potential method of diagnosis of early gastric cancer, since the first report in the 1990 s, people have been exploring in this field. Through intravenous injection of exogenous contrast medium, such as the indocyanine green, it makes mucosal lesions highlight,and avoids the interference of background light.If specific target molecular is linked to the contrast medium,the specific imaging of the lesion can be presented. What is more,due to the strong penetration power of infrared light,its imaging depth also increases significantly.Indocyanine green had also been demonstrated safe in clinical studies and widely used, such assessment of liver function tests.
At present,the research in this aspect is very few, a few clinical research results show that infrared endoscopic imaging has a larger value for differentiating between early gastric cancer and gastric adenoma, and the difference between early gastric cancer and gastric lesions is significantly correlated with the depth of cancer invasion.
However, there is not a system research about the infrared imaging characteristics of gastric cancer and different precancerous status,and there is no infrared endoscopic imaging assessment criteria for diagnosis of gastric cancer.
Recently, the investigators have completed the experiments on animals about infrared imaging, the results prove that it has good specificity to identify tumor lesion. On this basis,the investigators apply for the research about near-infrared endoscopy to diagnose early gastric cancer,and discuss its feasibility of the infrared endoscopy to diagnose early gastric cancer and clinical value.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer group | Experimental | Device: infrared endoscopyAll patients receive the infrared endoscopy after injecting indocyanine green（ICG） intravenously. |
| Non-cancer group | Other | Device: infrared endoscopyAll patients receive the infrared endoscopy after injecting ICG intravenously. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age：18-70
- Sex：unlimited；
- Group 1：patients with EGC，willing to receive treatment under endoscopy（EMR/ESD）
- Group 2：patients for screening，or have some general symptoms dyspepsia、epigastric pain）who need to be examined by endoscopy
- Informed consent issued
Key exclusion criteria (7 listed)
- Severe liver and kidney disease;
- Iodine, seafood or other severe allergies history；
- Patients with severe heart or pulmonary disease which is not suitable for endoscopic examination
- Higher blood risk of esophageal varices
- Pregnant or lactating female
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 |
|---|---|---|
| infrared endoscopyFirstly use standard white light and narrow-band imaging to observe the lesion, and then inject the contrast medium ICG, after 2 minutes,switch to infrared light to observe, record the image data, then accomplish the examination. | Device | Cancer group, Non-cancer group |
Primary outcome
the lesion of early gastric cancer by infrared endoscopy
Time frame: up to two years
confirming that the lesion of early gastric cancer can gather indocyanine green and can be observed by the infrared endoscopy.
1 secondary outcome
the invasive depth of early gastric cancer by infrared endoscopy
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Individual participant dataSharing planned: Yes
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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.
Lu Niu contact
Kaichun Wu, M.D., Prof. study director
Xijing Hospital of Digestive Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infrared endoscopy in people with Early Gastric Cancer, run by Xijing Hospital of Digestive Diseases 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 5 inclusion and 7 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 22 Mar 2016. 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.
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 Shuhui Liang, M.D. (86-13572885507, liangsh@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the lesion of early gastric cancer by infrared endoscopy (time frame: up to two years). 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 22 Mar 2016.