Clinical trial NCT00005809: Computerized Tomographic Colonography Compared With Standard Diagnostic Procedures in Detecting Colorectal Neoplasia
Official title: Computerized Tomographic Colonography: Performance Evaluation in a Multicenter Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colon cancer
rectal cancer
Lead sponsor: American College of Radiology Imaging Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-04-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colorectal neoplasia.

PURPOSE: Diagnostic study to compare the effectiveness of computerized tomographic colonography with that of standard diagnostic procedures in detecting colorectal neoplasia.

Detailed description: OBJECTIVES: I. Compare retrospectively the accuracy of computerized tomographic colonography (CTC) vs pathology and colonoscopy in the detection of clinically important colorectal neoplasia, defined as at least one proven lesion with a diameter measuring at least 1 cm. II. Compare the physician image display preferences and interpretation time across three viewing platforms for CTC images.

OUTLINE: This is a retrospective, multicenter study. Radiologists evaluate each patient's optimal diagnostic computerized tomographic colonography (CTC) data. Patients' CTC findings are evaluated by a radiologist at a central facility using an imaging display software platform from General Electric, Vital Images, or the Mayo Clinic. CTC findings are compared with conventional colonoscopy findings and pathologic analysis. A comparison is made between physician image display preferences and interpretation time across three viewing platforms for CTC images.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS: The following case material must be submitted for each patient: No colonic diseases except polyps, cancer, or diverticulosis Optimal diagnostic computerized tomographic colonography (CTC) data with computed tomography acquisition parameters that meet the following minimal standards: Slice thickness no greater than 5 mm Reconstruction interval no greater than 3 mm Pitch no greater than 2 Anatomic coverage of the entire colorectum Supine and prone data sets Complete colonoscopy performed within 30 days following CTC by a board certified gastroenterologist or a physician with at least 3 years of colonoscopic experience Pathology reports for all endoscopically or surgically removed colorectal lesions with the exception of polyps that are inadvertently dropped at the time of retrieval Photograph or videotape record of dropped lesion allowed as proof of its existence All studies are allowed including those with lesions less than 1 cm, lesions at least 1 cm, or no lesions Report documents size, site, stage, grade, and type of colorectal cancers; size, site, degree of dysplasia, and type of colorectal adenomas; and types of other lesions (e.g., inflammatory, vascular, ulcerative) Demographic data including patient's age, sex, ethnic background, symptoms, risk factors, and relevant clinical history

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Comprehensive Cancer Center
state: Alabama
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: San Francisco
country: United States
facility: Veterans Affairs Medical Center - San Francisco
state: California
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Louis
country: United States
facility: Mallinckrodt Institute of Radiology
state: Missouri
city: New York
country: United States
facility: NYU School of Medicine's Kaplan Comprehensive Cancer Center
state: New York
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
state: North Carolina
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Mayo Clinic
name: C. Daniel Johnson, MD
role: STUDY_CHAIR
References:
citation: Johnson CD, Toledano AY, Herman BA, Dachman AH, McFarland EG, Barish MA, Brink JA, Ernst RD, Fletcher JG, Halvorsen RA Jr, Hara AK, Hopper KD, Koehler RE, Lu DS, Macari M, Maccarty RL, Miller FH, Morrin M, Paulson EK, Yee J, Zalis M; American College of Radiology Imaging Network A6656. Computerized tomographic colonography: performance evaluation in a retrospective multicenter setting. Gastroenterology. 2003 Sep;125(3):688-95. doi: 10.1016/s0016-5085(03)01058-8.