NCT01366586

Brief Summary

The study aims to:

  1. 1.Achieve molecular imaging of MG7 antigen in patients with gastric cancer in vivo using confocal laser endomicroscopy.
  2. 2.Compare the results of in vivo MG7-specific molecular imaging with CLE and ex vivo immunohistochemistry .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 30, 2011

Status Verified

December 1, 2011

Enrollment Period

2 months

First QC Date

June 2, 2011

Last Update Submit

December 27, 2011

Conditions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with endoscopically diagnosed gastric cancer

You may qualify if:

  • patients with endoscopically diagnosed gastric cancer

You may not qualify if:

  • Patients who are allergic to fluorescein sodium
  • Patients who are unwilling to sign or give the informed consent form
  • Patients with giant tumors or obvious GI tract bleeding which make it hard or impossible to observe the lesions
  • Patients with impaired cardiac, liver or renal function
  • Patients with coagulopathy
  • Patients with pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Taken biopsies during endoscopy

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Yanqing Li, MD, PhD

    Department of Gastroenterology, Qilu Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 6, 2011

Study Start

May 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 30, 2011

Record last verified: 2011-12

Locations