Clinical trial NCT00997802: Japanese National Computed Tomographic (CT) Colonography Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyps
Colonic Neoplasms
Keywords: Computed Tomographic Colonography
Colonic Polyps
Colonic Neoplasms
Computer Aided Diagnosis
Lead sponsor: Japanese CT Colonography Society
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 1257
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: sensitivity in the detection of colorectal polyps and cancers in CTC
timeFrame: 1.5 years
Secondary outcomes:
measure: specificity and predictive values in the detection of colorectal polyps and cancers in CTC.
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital
state: Massachusetts
city: Otaru
country: Japan
facility: Otarukyokai Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Tonan Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Social Insurance Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Gastroenterology Hospital
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Showa University Northern Yokohama Hospital
state: Kanagawa
city: Kamigoto
country: Japan
facility: Kamigoto Hospital
state: Nagasaki
city: Kurashiki
country: Japan
facility: Kawasaki Medical School
state: Okayama
city: Hamamatsu
country: Japan
facility: Hamamatsu South Hospital
state: Shizuoka
city: Shimono
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Arakawa-ku
country: Japan
facility: Tokyo Women's Medical University Medical Center East
state: Tokyo
Study officials:
affiliation: Japanese CTC Society
name: Koichi Nagata, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.