Impact of Computer-Aided Detection (CAD) as Second Reader in CT Colonography (CAD-IMPACT)

July 21, 2011 updated by: im3D S.p.A.

Measure of Performances of CT Colonography With Computer-Aided Detection (CAD) as Second Reader in Detecting Colorectal Lesion

RATIONALE: CT colonography accurately detects large polyps and masses. However, the test is less accurate in identifying lesions between 6 and 9 mm.Use of computer-aided detection (CAD) has shown promising results in providing uniform accuracy and improving CT colonography sensitivity.

PURPOSE:This clinical trial compared the performance of CT colonography with unassisted and CAD-assisted reading in detecting patients with colorectal lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design: multicenter, cross-sectional study. Each participant underwent CT colonography and colonoscopy on the same day. Expert readers interpreted CT colonography unassisted and then reviewed all colorectal lesion-like structures pinpointed by the CAD algorithm.

Study Type

Interventional

Enrollment (Actual)

651

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- clinical indication to undergo colonoscopy either for symptoms, or participating a surveillance program or a CRC screening

Exclusion Criteria:

  • clinical diagnosis of familial adenomatous polyposis or hereditary nonpolyposis CRC syndrome
  • inflammatory bowel disease
  • celiac disease
  • evidence of increased risk of harm from colonoscopy
  • psychological or physical conditions that contraindicated colonoscopy or CT Colonography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm
Specificity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with no clinical relevant lesions

Secondary Outcome Measures

Outcome Measure
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 10 mm or larger
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting lesions 6 mm or larger

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

im3D S.p.A.

Collaborators

University of Pisa
IRCCS Azienda Ospedaliero-Universitaria di Bologna
University of Roma La Sapienza
Valduce Hospital
University of Turin, Italy
University of Florence
Fondazione Salvatore Maugeri
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Candiolo Cancer Institute - IRCCS
Catholic University, Italy
Nuovo Regina Margherita Hospital
Bicocca Universiy of Milano, Milan, Italy

Investigators

  • Principal Investigator: Daniele Regge, Institute Institute for Cancer Research and Treatment, Candiolo, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 15, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 21, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAD COLON 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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