Colorectal Cancer
Conditions
Keywords
colon cancer, rectal cancer
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECT Colonography
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
Sponsors
National Cancer Institute (NCI)
American College of Radiology Imaging Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion Criteria * Male or female outpatients * Aged 50 years or older * Scheduled for screening colonoscopy * Participant's signed informed consent 2.
Exclusion criteria
* Symptoms of disease of the lower gastrointestinal tract, including * Melanotic stools or/and hematochezia on more than one occasion in the previous six months * Lower abdominal pain that would normally require a medical evaluation * Inflammatory bowel disease and/or familial polyposis syndrome * Serious medical conditions that would increase the risk associated with colonoscopy or are so severe that screening would have no benefit * Pregnancy * Previous colonoscopy within the past five years * Anemia (hemoglobin less than 10 gm/dl) * Positive fecal occult blood test (FOBT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient) | within 30 days | 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) |
| Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient) | within 30 days | 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) |
| Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient) | within 30 days | 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) |
| Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient) | within 30 days | 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) |
| Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient) | within 30 days | 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) |
| Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient) | within 30 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion) | within 30 days | 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 |
| Interobserver Sensitivity Variability | at baseline | 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 |
| Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion) | within 30 days | 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 |
| Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion) | within 30 days | 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 |
| Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion) | within 30 days | 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 |
| Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion) | within 30 days | 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 |
| Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion) | within 30 days | 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 |
Countries
United States
Participant flow
Recruitment details
2600 asymptomatic, out-patients, 50 years or older and prescheduled for screening colonoscopy were recruited for CTC between February 2005 and December 2006.
Pre-assignment details
Of the 2607 registration events, 7 were registration errors \[duplicate registrations due to system errors\] and were cancelled. Therefore, a total of 2600 unique participants were enrolled to the study.
Participants by arm
| Arm | Count |
|---|---|
| CT Colonography CT colonography conducted during the same assessment as colonoscopy.
CT Colonography: CT colonography performed for comparison with colonoscopy results performed during the same screening assessment. | 2,531 |
| Total | 2,531 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | ineligible - medical contraindication | 1 |
| Overall Study | Ineligible - Medical history | 6 |
| Overall Study | ineligible - Pre-scheduled procedure not | 1 |
| Overall Study | Missing/incomplete CTC exam | 9 |
| Overall Study | Missing Reference Standard (Colonoscopy) | 42 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | CT Colonography |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 97 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2430 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants |
| Race (NIH/OMB) Asian | 54 Participants |
| Race (NIH/OMB) Black or African American | 325 Participants |
| Race (NIH/OMB) More than one race | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 44 Participants |
| Race (NIH/OMB) White | 2075 Participants |
| Sex: Female, Male Female | 1326 Participants |
| Sex: Female, Male Male | 1205 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,600 | 0 / 2,600 |
| other Total, other adverse events | 0 / 2,600 | 0 / 2,600 |
| serious Total, serious adverse events | 0 / 2,600 | 1 / 2,600 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT Colonography | Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient) | RS+ | 109 Participants |
| CT Colonography | Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient) | RS- | 2422 Participants |
Comparison: Accuracy: ROC analysis Receiver-operating-characteristic (ROC) curves were estimated with the use of data pooled from the radiologists because of the small number of positive cases reviewed by each radiologist.95% CI: [0.853, 0.933]
Comparison: Sensitivity, for each radiologist, was calculated as the percentage of patients with lesions that were larger than or equal to the prespecified threshold and that were detected on both colonoscopy and CT colonography.~The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated.95% CI: [0.838, 0.96]
Comparison: Specificity, for each radiologist, was calculated as the percentage of patients who did not have lesions larger than the prespecified threshold on colonoscopy as well as CT colonography The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated.95% CI: [0.813, 0.9]
Comparison: Positive Predictive Value (PPV) the positive predictive value was calculated as the percentage of patients with CT colonographic findings that were also seen on colonoscopy95% CI: [0.194, 0.273]
Comparison: Negative Predictive Value (NPV) the negative predictive value was calculated as the percentage of patients with no CT colonographic findings larger than the prespecified threshold that were not detected on colonoscopy.95% CI: [0.99, 0.998]
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT Colonography | Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient) | RS+: Advanced Adenoma >=5mm | 282 Participants |
| CT Colonography | Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient) | RS-: Not Advanced Adenoma >=5mm | 2249 Participants |
Comparison: Accuracy: ROC analysis95% CI: [0.763, 0.828]
Comparison: Sensitivity95% CI: [0.579, 0.727]
Comparison: Specificity95% CI: [0.851, 0.923]
Comparison: Positive Predictive Value (PPV)95% CI: [0.389, 0.513]
Comparison: Negative Predictive Value (NPV)95% CI: [0.941, 0.965]
Primary
Number of Participants With Advanced Adenomas (>=6mm) 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 \>=6mm (as measured at pathology) RS-: No Advanced adenomas \>=16mm found by colonoscopy (as measured at pathology)
Time frame: within 30 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT Colonography | Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient) | RS+: Advanced Adenoma >=6mm | 210 Participants |
| CT Colonography | Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient) | RS-: Not Advanced Adenoma >=6mm | 2321 Participants |
Comparison: Accuracy: ROC analysis95% CI: [0.81, 0.878]
Comparison: Sensitivity95% CI: [0.711, 0.849]
Comparison: Specificity95% CI: [0.84, 0.92]
Comparison: Positive Predictive Value (PPV)95% CI: [0.335, 0.463]
Comparison: Negative Predictive Value (NPV)95% CI: [0.971, 0.984]
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT Colonography | Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient) | RS+: Advanced Adenoma >=7mm | 174 Participants |
| CT Colonography | Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient) | RS-: Not Advanced Adenoma >=7mm | 2357 Participants |
Comparison: Accuracy: ROC analysis95% CI: [0.833, 0.902]
Comparison: Sensitivity95% CI: [0.776, 0.912]
Comparison: Specificity95% CI: [0.831, 0.914]
Comparison: Positive Predictive Value (PPV)95% CI: [0.299, 0.397]
Comparison: Negative Predictive Value (NPV)95% CI: [0.98, 0.992]
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT Colonography | Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient) | RS+: Advanced Adenoma >=8mm | 154 Participants |
| CT Colonography | Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient) | RS-: Not Advanced Adenoma >=8mm | 2377 Participants |
Comparison: Accuracy: ROC analysis95% CI: [0.842, 0.913]
Comparison: Sensitivity95% CI: [0.803, 0.929]
Comparison: Specificity95% CI: [0.825, 0.909]
Comparison: Positive Predictive Value (PPV)95% CI: [0.256, 0.355]
Comparison: Negative Predictive Value (NPV)95% CI: [0.984, 0.994]
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT Colonography | Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient) | RS+: Advanced Adenoma >=9mm | 120 Participants |
| CT Colonography | Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient) | RS-: Not Advanced Adenoma >=9mm | 2411 Participants |
Comparison: Accuracy: ROC analysis CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected95% CI: [0.853, 0.93]
Comparison: Sensitivity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected95% CI: [0.832, 0.96]
Comparison: Specificity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected95% CI: [0.817, 0.902]
Comparison: Positive Predictive Value (PPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected95% CI: [0.209, 0.292]
Comparison: Negative Predictive Value (NPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected95% CI: [0.99, 0.998]
Secondary
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
Population: 15 readers read the 2531 case and their sensitivity was calculated as well as the variability (95% CI) in Sensitivity within 2 reader groups: High performing (HP) and not high performing (NHP). HP readers had both a sensitivity and specificity of \> 85% for detecting polyps 10 mm and larger, NHP did not.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CT Colonography | Interobserver Sensitivity Variability | 0.94 probability of (test+ given disease+) |
| Non-high Performance (NHP) Readers | Interobserver Sensitivity Variability | 0.88 probability of (test+ given disease+) |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion) | Detected by CTC | 108 lesions |
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion) | Not Detected | 20 lesions |
Comparison: Sensitivity (per lesion (\>=10mm))
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion) | Detected by CTC | 221 lesions |
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion) | Not Detected | 153 lesions |
Comparison: Sensitivity (per lesion \>=5mm)
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion) | Detected by CTC | 189 lesions |
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion) | Not Detected | 81 lesions |
Comparison: Sensitivity (per lesion \>=6mm)
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion) | Detected by CTC | 165 lesions |
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion) | Not Detected | 55 lesions |
Comparison: Sensitivity (per lesion \>=7mm)
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion) | Detected by CTC | 149 lesions |
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion) | Not Detected | 38 lesions |
Comparison: Sensitivity (per lesion \>=8mm)
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion) | Detected by CTC | 117 lesions |
| CT Colonography | Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion) | Not Detected | 26 lesions |
Comparison: Sensitivity (per lesion (\>=9mm))