NCT02710838

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

2.4 years

First QC Date

February 29, 2016

Last Update Submit

March 18, 2016

Conditions

Early Gastric Cancer

Keywords

Early gastric cancerInfrared endoscope

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to two years

Secondary Outcomes (1)

  • the invasive depth of early gastric cancer by infrared endoscopy

    two years

Study Arms (2)

Cancer group

EXPERIMENTAL

All patients receive the infrared endoscopy after injecting indocyanine green（ICG） intravenously.

Device: infrared endoscopy

Non-cancer group

OTHER

All patients receive the infrared endoscopy after injecting ICG intravenously.

Device: infrared endoscopy

Interventions

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.

Cancer groupNon-cancer group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Kaichun Wu, M.D., Prof.

    Xijing Hospital of Digestive Diseases

    STUDY DIRECTOR

Central Study Contacts

Shuhui Liang, M.D.

CONTACT

86-13572885507liangsh@fmmu.edu.cn

Lu Niu

CONTACT

710257073@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 17, 2016

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

February 1, 2017

Last Updated

March 22, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Locations

CN(1)