RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection. PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.
OBJECTIVES: Primary * Compare the sensitivity of computed tomographic colonography (CTC) vs colonoscopy for detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic participants, in terms of specificity, area under the ROC curve, and predictive values for detecting clinically significant colorectal neoplasia. Secondary * Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants, including any benefits of a primary 3-dimensional read and/or independent second interpretations. * Determine the effects of different colon preparations on the accuracy of CTC in these participants. * Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy. * Determine the accuracy of CTC in detecting flat lesions in the colon of these participants. OUTLINE: This is a multicenter study. Participants receive an oral laxative, oral bisacodyl, and three doses of oral barium sulphate 24 hours before imaging. After cathartic cleansing, participants undergo computed tomographic colonography followed by colonoscopy. Participants are followed up for approximately 4 weeks. PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
2,600
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Moores UCSD Cancer Center
La Jolla, California, United States
Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=10mm (as measured at pathology) RS-: No Advanced adenomas \>=10mm found by colonoscopy (as measured at pathology)
Time frame: within 30 days
Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=9mm (as measured at pathology) RS-: No Advanced adenomas \>=9mm found by colonoscopy (as measured at pathology)
Time frame: within 30 days
Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=8mm (as measured at pathology) RS-: No Advanced adenomas \>=8mm found by colonoscopy (as measured at pathology)
Time frame: within 30 days
Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=7mm (as measured at pathology) RS-: No Advanced adenomas \>=7mm found by colonoscopy (as measured at pathology)
Time frame: within 30 days
Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient)
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Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
Invision/Radiology Imaging Associates - Englewood
Englewood, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Clinical Radiologists, S.C. at Memorial Medical Center
Springfield, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
...and 4 more locations
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=6mm (as measured at pathology) RS-: No Advanced adenomas \>=16mm found by colonoscopy (as measured at pathology)
Time frame: within 30 days
Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas \>=5mm (as measured at pathology) RS-: No Advanced adenomas \>=5mm found by colonoscopy (as measured at pathology)
Time frame: within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
Time frame: within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
Time frame: within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
Time frame: within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
Time frame: within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
Time frame: within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion)
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
Time frame: within 30 days
Interobserver Sensitivity Variability
Evaluate interobserver variability in Sensitivity (P(T+\|D+)) and 95% CI) when interpreting CTC examinations Each study was randomly assigned to be read independently using either a primary 2D search method (conventional 2D image display with 3D endoluminal problem solving), or a primary 3D search method (including the capability of displaying multiplanar 2D) and without prior knowledge of the colonoscopy results. A second trained radiologist of similar skill was assigned to read the images using the other modality Readers were then classified as high performing or not high performing
Time frame: at baseline