NCT01200303

Brief Summary

The purpose of this study is to evaluate the performance of a non-cathartic, computer-assisted form of CT Colonography (Virtual Colonoscopy) for detection of pre-cancerous colon polyps in a group of asymptomatic screening patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
605

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

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

June 1, 2005

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

5.3 years

First QC Date

September 9, 2010

Last Update Submit

August 3, 2015

Conditions

Colonic Polyps

Keywords

colon canceradenomatous colonic polypscolon screeningCT Colonography (Virtual Colonoscopy)Computer Aided DetectionElectronic Cleansing

Outcome Measures

Primary Outcomes (1)

  • Performance for detection of adenomatous colonic polyps > 6mm

    this is a prospective test comparison of non-cathartic, CAD-assisted CT Colonography to segmentally unblinded optical colonoscopy (OC), latter serving with pathology specimens as reference standard for presence of polyps.

    on per subject basis, metric will be assessed at unblinding OC (w/i 5 weeks enrollment); for cohort, summary statistics will be generated at study completion

Secondary Outcomes (1)

  • Patient comfort associated with non-cathartic exam preparation

    on per subject basis, outcome will be assessed at 5 weeks post enrollment (following OC); for cohort, summary statistics will be generated at study completion

Study Arms (1)

non-cathartic CTC and OC

ACTIVE COMPARATOR

This is a single arm, open label, prospective test comparison of non-cathartic, CAD-assisted CTC to segmentally unblinded optical colonoscopy (OC). All study subjects receive both tests, starting with CTC, followed by OC within 5 weeks. CTC results are recorded and revealed to endoscopist on a segment-by-segment basis after initial (blinded) OC evaluation; endoscopist can double check / confirm lesion presence after unblinding and this second read serves as reference standard.

Procedure: non-cathartic CTC

Interventions

non-cathartic CTCPROCEDURE

non-cathartic, CAD-assisted CT Colonography

Also known as: tagging of non-cathartic CTC employs iohexol (Omnipaque 300)
non-cathartic CTC and OC

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 50-80, eligible for colon screening

You may not qualify if:

  • prior anatomic colon screening exam (optical colonoscopy, sigmoidoscopy, barium enema, CT Colonography) within last 5 years
  • personal history of inflammatory bowel disease, polyposis syndrome, colo-rectal cancer, colon surgery
  • documented passage of blood per rectum within last 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCSF-VA Medical Center

San Francisco, California, 94121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Zalis ME, Blake MA, Cai W, Hahn PF, Halpern EF, Kazam IG, Keroack M, Magee C, Nappi JJ, Perez-Johnston R, Saltzman JR, Vij A, Yee J, Yoshida H. Diagnostic accuracy of laxative-free computed tomographic colonography for detection of adenomatous polyps in asymptomatic adults: a prospective evaluation. Ann Intern Med. 2012 May 15;156(10):692-702. doi: 10.7326/0003-4819-156-10-201205150-00005.

    PMID: 22586008RESULT

MeSH Terms

Conditions

Colonic PolypsColonic Neoplasms

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Michael Zalis, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 13, 2010

Study Start

June 1, 2005

Primary Completion

October 1, 2010

Study Completion

January 1, 2011

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

US(3)