Japanese National Computed Tomographic (CT) Colonography Trial

NCT ID: NCT00997802

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2017-01-31

Brief Summary

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.

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.

Conditions

Colonic Polyps; Colonic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CT colonography and optical colonoscopy

Group Type: OTHER

CT colonography and optical colonoscopy

Intervention Type: DEVICE

All patients will undergo CT colonography and optical colonoscopy.

Interventions

CT colonography and optical colonoscopy

All patients will undergo CT colonography and optical colonoscopy.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japanese CT Colonography Society

OTHER

Sponsor Role: lead

Responsible Party

Hiroyuki Yoshida

3D Imaging Laboratory, Massachusetts General Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Koichi Nagata, MD, PhD

Role: STUDY_DIRECTOR

Japanese CTC Society

Locations

Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital

Boston, Massachusetts, United States

Otarukyokai Hospital

Otaru, Hokkaido, Japan

Tonan Hospital

Sapporo, Hokkaido, Japan

Hokkaido Social Insurance Hospital

Sapporo, Hokkaido, Japan

Hokkaido Gastroenterology Hospital

Sapporo, Hokkaido, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Showa University Northern Yokohama Hospital

Yokohama, Kanagawa, Japan

Kamigoto Hospital

Kamigotō, Nagasaki, Japan

Kawasaki Medical School

Kurashiki, Okayama-ken, Japan

Hamamatsu South Hospital

Hamamatsu, Shizuoka, Japan

Jichi Medical University Hospital

Shimono, Tochigi, Japan

Tokyo Women's Medical University Medical Center East

Arakawa-ku, Tokyo, Japan

Countries

United States; Japan

References

Nagata K, Endo S, Honda T, Yasuda T, Hirayama M, Takahashi S, Kato T, Horita S, Furuya K, Kasai K, Matsumoto H, Kimura Y, Utano K, Sugimoto H, Kato H, Yamada R, Yamamichi J, Shimamoto T, Ryu Y, Matsui O, Kondo H, Doi A, Abe T, Yamano HO, Takeuchi K, Hanai H, Saida Y, Fukuda K, Nappi J, Yoshida H. Accuracy of CT Colonography for Detection of Polypoid and Nonpolypoid Neoplasia by Gastroenterologists and Radiologists: A Nationwide Multicenter Study in Japan. Am J Gastroenterol. 2017 Jan;112(1):163-171. doi: 10.1038/ajg.2016.478. Epub 2016 Oct 25.

Reference Type: RESULT

PMID: 27779195 (View on PubMed)

Related Links

http://www.nature.com/ajg/journal/v112/n1/full/ajg2016478a.html

Original Contributions

Other Identifiers

UMIN000002097

Identifier Type: -

Identifier Source: org_study_id