NCT01372189

Brief Summary

The study aims to:

  1. 1.Achieve molecular imaging of EGFR in patients with colorectal neoplasia in vivo using confocal laser endomicroscopy.
  2. 2.Compare the results of in vivo EGFR-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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 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

January 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed
18 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

February 1, 2012

Status Verified

January 1, 2012

Enrollment Period

6 months

First QC Date

January 18, 2011

Last Update Submit

January 30, 2012

Conditions

Colorectal CancerColorectal Adenoma

Keywords

molecular imagingepidermal growth factor receptorcolorectal neoplasiaconfocal laser endomicroscopy

Study Arms (2)

colorectal cancer

Patients with colorectal carcinoma during conventional endoscopic imaging.

colorectal adenoma

Patients with colorectal adenoma during conventional endoscopic imaging.

Eligibility Criteria

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

patients known to have large polypoid lesions in colon or rectum from previous examinations from outpatients and inpatients at Qilu Hospital were enrolled into the study

You may qualify if:

  • ●Patients known to have large polypoid lesions in colon or rectum from previous examinations from outpatients and inpatients at Qilu Hospital were enrolled into the study

You may not qualify if:

  • Patients who are allergic to fluorescein sodium
  • Patients with impaired cardiac, liver or renal function
  • 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 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, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Take biospecimen during colonoscopy.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Yanqing Li, PhD. MD.

    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

January 18, 2011

First Posted

June 13, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 1, 2012

Record last verified: 2012-01

Locations

CN(1)