Trial Outcomes & Findings for The National CT Colonography Trial (NCT NCT00084929)

NCT ID: NCT00084929

Last Updated: 2020-12-22

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2600 participants
• Primary outcome timeframe: within 30 days
• Results posted on: 2020-12-22

Participant Flow

2600 asymptomatic, out-patients, 50 years or older and prescheduled for screening colonoscopy were recruited for CTC between February 2005 and December 2006.

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.

Participant milestones

Measure	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.
Overall Study STARTED	2600
Overall Study COMPLETED	2531
Overall Study NOT COMPLETED	69

Reasons for withdrawal

Measure	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.
Overall Study ineligible - medical contraindication	1
Overall Study ineligible - Pre-scheduled procedure not	1
Overall Study Ineligible - Medical history	6
Overall Study Withdrawal by Subject	10
Overall Study Missing/incomplete CTC exam	9
Overall Study Missing Reference Standard (Colonoscopy)	42

Baseline Characteristics

The National CT Colonography Trial

Baseline characteristics by cohort

Measure	CT Colonography n=2531 Participants 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.
Age, Continuous	58 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	1326 Participants n=5 Participants
Sex: Female, Male Male	1205 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2430 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	10 Participants n=5 Participants
Race (NIH/OMB) Asian	54 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	325 Participants n=5 Participants
Race (NIH/OMB) White	2075 Participants n=5 Participants
Race (NIH/OMB) More than one race	20 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	CT Colonography n=2531 Participants 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient) RS+	109 Participants	—
Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient) RS-	2422 Participants	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	CT Colonography n=2531 Participants 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient) RS+: Advanced Adenoma >=9mm	120 Participants	—
Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient) RS-: Not Advanced Adenoma >=9mm	2411 Participants	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	CT Colonography n=2531 Participants 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient) RS+: Advanced Adenoma >=8mm	154 Participants	—
Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient) RS-: Not Advanced Adenoma >=8mm	2377 Participants	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	CT Colonography n=2531 Participants 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient) RS+: Advanced Adenoma >=7mm	174 Participants	—
Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient) RS-: Not Advanced Adenoma >=7mm	2357 Participants	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	CT Colonography n=2531 Participants 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient) RS+: Advanced Adenoma >=6mm	210 Participants	—
Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient) RS-: Not Advanced Adenoma >=6mm	2321 Participants	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	CT Colonography n=2531 Participants 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient) RS+: Advanced Adenoma >=5mm	282 Participants	—
Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient) RS-: Not Advanced Adenoma >=5mm	2249 Participants	—

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	CT Colonography n=128 lesions 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion) Detected by CTC	108 lesions	—
Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion) Not Detected	20 lesions	—

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	CT Colonography n=143 lesions 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion) Detected by CTC	117 lesions	—
Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion) Not Detected	26 lesions	—

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	CT Colonography n=187 lesions 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion) Detected by CTC	149 lesions	—
Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion) Not Detected	38 lesions	—

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	CT Colonography n=220 lesions 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion) Detected by CTC	165 lesions	—
Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion) Not Detected	55 lesions	—

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	CT Colonography n=270 lesions 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion) Detected by CTC	189 lesions	—
Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion) Not Detected	81 lesions	—

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	CT Colonography n=374 lesions 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.	Non-high Performance (NHP) Readers NHP readers had a sensitivity and/or specificity \< 85%.
Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion) Detected by CTC	221 lesions	—
Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion) Not Detected	153 lesions	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	CT Colonography n=8 Readers 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.	Non-high Performance (NHP) Readers n=7 Readers NHP readers had a sensitivity and/or specificity \< 85%.
Interobserver Sensitivity Variability	0.94 probability of (test+ given disease+) Interval 0.825 to 0.987	0.88 probability of (test+ given disease+) Interval 0.864 to 0.901

Adverse Events

CT Colonography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Colonoscopy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	CT Colonography n=2600 participants at risk 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.	Colonoscopy n=2600 participants at risk Colonoscopy conducted during the same assessment as CT colonography
Gastrointestinal disorders hemorrhage with surgery	0.00% 0/2600 • The adverse event reporting period for this protocol is defined as the period from the initiation of the Computed Tomography Colonography (CTC) procedure and self-reported events were collected for 30 days after the last primary intervention. All participants were monitored for 30days. Grade 3 Expected and Unexpected AEs with attribution of possible, probable, or definite - Routine Grade 4 Expected AEs with attribution of possible, probable, or definite - Routine Grade 4 Unexpected AEs with attribution of possible, probable, or definite Expedited Report. Grade 5 AEs, or Deaths with attribution of possible, probable, or definite Telephone Report and Expedited Report	0.04% 1/2600 • Number of events 1 • The adverse event reporting period for this protocol is defined as the period from the initiation of the Computed Tomography Colonography (CTC) procedure and self-reported events were collected for 30 days after the last primary intervention. All participants were monitored for 30days. Grade 3 Expected and Unexpected AEs with attribution of possible, probable, or definite - Routine Grade 4 Expected AEs with attribution of possible, probable, or definite - Routine Grade 4 Unexpected AEs with attribution of possible, probable, or definite Expedited Report. Grade 5 AEs, or Deaths with attribution of possible, probable, or definite Telephone Report and Expedited Report

Other adverse events

Adverse event data not reported

Additional Information

Donna Harfeil, Director of Protocol Management

ACRIN

Phone: 215-717-2765

Email: dhartfeil@acr.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place