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

Colorectal Cancer Clinical Trial

— ACRIN 6656  

Official title:

Computerized Tomographic Colonography: Performance Evaluation in a Multicenter Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005809
• Other study ID #: CDR0000067802
• Secondary ID: ACRIN-6656CA8009
• Status: Completed
• Phase: N/A
• First received: June 2, 2000
• Last updated: February 1, 2013
• Start date: July 2000
• Est. completion date: January 2003

Study information

• Verified date: February 2013
• Source: American College of Radiology Imaging Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2003
• Est. primary completion date: October 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Procedure:
• computed tomography

• diagnostic colonoscopy

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Mallinckrodt Institute of Radiology	Saint Louis	Missouri
United States	Veterans Affairs Medical Center - San Francisco	San Francisco	California
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology Imaging Network	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 R — View Citation