Computerized Tomographic Colonography Compared With Standard Diagnostic Procedures in Detecting Colorectal Neoplasia

NCT ID: NCT00005809

Last Updated: 2013-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2003-01-31

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.

Conditions

Colorectal Cancer

Study Design

• Primary Study Purpose: DIAGNOSTIC

Interventions

computed tomography

Intervention Type: PROCEDURE

diagnostic colonoscopy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

American College of Radiology Imaging Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

C. Daniel Johnson, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, United States

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Veterans Affairs Medical Center - San Francisco

San Francisco, California, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Boston Medical Center

Boston, Massachusetts, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Mallinckrodt Institute of Radiology

St Louis, Missouri, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 12949715 (View on PubMed)

Other Identifiers

ACRIN-6656

Identifier Type: -

Identifier Source: secondary_id

CA80098

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDR0000067802

Identifier Type: -

Identifier Source: org_study_id