Japanese National Computed Tomographic (CT) Colonography Trial - Full Text View

Sponsor:	Japanese CT Colonography Society
Information provided by:	Japanese CT Colonography Society
ClinicalTrials.gov Identifier:	NCT00997802

Purpose

The purpose of this study is to evaluate the sensitivity of computed tomographic colonography (CTC) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard.

Condition	Intervention
Colonic Polyps Colonic Neoplasms	Device: CT colonography and optical colonoscopy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Evaluation of Accuracy of Computed Tomographic Colonography (CTC) in the Diagnosis of Colorectal Tumors by Gastroenterologists and Radiologists With Computer-aided Detection (CAD): A Multicenter Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colonic Polyps Colonoscopy Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Japanese CT Colonography Society:

Primary Outcome Measures:

sensitivity in the detection of colorectal polyps and cancers in CTC [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

specificity and predictive values in the detection of colorectal polyps and cancers in CTC. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	1500
Study Start Date:	October 2009
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CT colonography and optical colonoscopy	Device: CT colonography and optical colonoscopy All patients will undergo CT colonography and optical colonoscopy.

Detailed Description:

The investigators will evaluate the sensitivity of CTC in detecting colorectal polyps and cancers (at least 6 mm in diameter) in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard. The primary endpoint will be sensitivity in the detection of colorectal polyps and cancers that are at least 6 mm in diameter. The secondary endpoints will include specificity and predictive values in the detection of colorectal polyps and cancers.

This clinical study will also evaluate the differences of the detection accuracies between human readings with and without computer-aided detection (CAD) that automatically detects colonic lesions in CTC images and presents the detected lesions to the readers. This clinical study will also compare performance between radiologists and gastroenterologists in detecting colorectal lesions in CTC images.

All the CTC images and their interpretations, optical colonoscopy reports and images, and pathology reports of resected colorectal lesion will be prospectively collected from 12 Japanese hospitals participating in the trial. All patients' information will be completely anonymized at each site before any analysis of the data takes place.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Outpatients who are eligible for optical colonoscopy.
Aged 20 years or older.
Major functions of organs of the subjects are in a good condition.
Signed informed consent forms are obtained from the patients.

Exclusion Criteria:

Known colorectal polyps or cancers at any site at the time of enrollment.
Patients with inflammatory bowel disease.
Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.
Previous colorectal surgery.
Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
Evidence of an increased risk in carrying out bowel preparation or CTC exams.
Possibility of pregnancy.
Optical colonoscopy or barium enema carried out within the last 3 years.
Patients with psychological conditions that contraindicate colonoscopy or that make them irrelevant to participate in the trial.
Iodine hypersensitivity.
Severe thyroid disease.
Claustrophobia.
Severe deafness.
Subjects whose eligibility for this clinical trial is not appropriate by other reasons.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997802

Locations

United States, Massachusetts
Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Japan
Otarukyokai Hospital
Otaru, Hokkaido, Japan, 047-8510
Hokkaido Gastroenterology Hospital
Sapporo, Hokkaido, Japan, 065-0041
Hokkaido Social Insurance Hospital
Sapporo, Hokkaido, Japan, 062-8618
Tonan Hospital
Sapporo, Hokkaido, Japan, 060-0001
Kanazawa University Hospital
Kanazawa, Ishikawa, Japan, 920-8641
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, Japan, 224-8503
Kamigoto Hospital
Kamigoto, Nagasaki, Japan, 857-4404
Kawasaki Medical School
Kurashiki, Okayama, Japan, 701-0192
Hamamatsu South Hospital
Hamamatsu, Shizuoka, Japan, 430-0846
Jichi Medical University Hospital
Shimono, Tochigi, Japan, 329-0498
Tokyo Women's Medical University Medical Center East
Arakawa-ku, Tokyo, Japan, 116-8567

Sponsors and Collaborators

Japanese CT Colonography Society

Investigators

Study Director:

Koichi Nagata, MD, PhD

Japanese CTC Society

More Information

No publications provided

Responsible Party:	3D Imaging Laboratory, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00997802 History of Changes
Other Study ID Numbers:	UMIN000002097, JANCT-01
Study First Received:	October 18, 2009
Last Updated:	July 7, 2011
Health Authority:	United States: Institutional Review Board; Japan: Institutional Review Board

Keywords provided by Japanese CT Colonography Society:

Computed Tomographic Colonography
Colonic Polyps
Colonic Neoplasms
Computer Aided Diagnosis

Additional relevant MeSH terms:

Neoplasms
Colonic Neoplasms
Colonic Polyps
Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms

Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on February 09, 2012