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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

651 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Japanese National Computed Tomographic (CT) Colonography Trial

NCT00997802

Colonic Polyps Colonic Neoplasms

COMPLETED NA

Role of Computer-Aided Detection Colonoscopy in Polyp Detection Rate

NCT07171333

Colorectal Polyps

COMPLETED NA

Efficacy of CAD in Screening Colonoscopy to Reduce the Risk of Advanced Adenoma at 3 Years.

NCT07299071

Colonoscopy Colorectal Neoplasms Intestinal Polyps

NOT_YET_RECRUITING NA

Adenoma Detection Rate Using Endocuff Vision in China

NCT03839277

Colorectal Neoplasms Colonic Polyp Adenoma

SUSPENDED NA

A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )

NCT05523271

Colorectal Cancer

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Individuals With Suspected Colorectal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CT colonography

Participants were placed on a CT table and a small flexible rectal catheter was positioned. N-butyl-scopolamine was administered intravenously if this was common practice in the participating center. Immediately before scanning, pneumocolon was obtained through insufflation of room air or carbon dioxide, either manually by means of a balloon pump or with an automatic device, until maximum tolerance was reached. CT colonography was performed with the participant in supine and prone positions with the following scanning protocol: 120 kilovolt peak (kVp), 50 or fewer effective mA per second, and a section thickness not greater than 1.25 mm.

Intervention Type PROCEDURE

colonoscopy

Colonoscopy was performed at least 3 hours after CT colonography. The endoscope was advanced to the cecum and the entire length of the bowel was examined during endoscope withdrawal. The endoscopist was initially blinded to the result of CT colonography; at the end of each bowel segment evaluation, CT colonography results for that segment were disclosed (segmental unblinding). If a lesion measuring 6 mm or larger was detected at CT colonography but not at colonoscopy, the segment was reexamined to resolve the discrepancy

Intervention Type PROCEDURE

CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy

Each CT colonography study was read in two phases. In the first phase the radiologist interpreted the examination without activating the CAD algorithm. This phase of reporting was defined as unassisted reading. Then the radiologist activated the CAD algorithm which pinpointed a series of colorectal lesion-like structures (i.e. lesion candidates) on both the prone and supine acquisition. All lesion candidates were examined. The second phase of reporting was defined as CAD-assisted reading.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No