Colorectal CancerACRIN6664NCT00084929

The National CT Colonography Trial

A study testing CT Colonography in people with Colorectal Cancer, run by American College of Radiology Imaging Network at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Colorectal Cancer
What is being tested?: CT Colonography
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,600 participants
Where: 14 sitesUnited States
Study dates: Feb 2005to 13 May 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Inclusion Criteria

Male or female outpatients
Aged 50 years or older
Scheduled for screening colonoscopy
Participant's signed informed consent

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)

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Invision/Radiology Imaging Associates - Englewood
Englewood, Colorado, 80112
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Moores UCSD Cancer Center
La Jolla, California, 92093-0658
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
Yale Cancer Center
New Haven, Connecticut, 06520-8028
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
Clinical Radiologists, S.C. at Memorial Medical Center
Springfield, Illinois, 62781
Mallinckrodt Institute of Radiology at Washington University Medical Center
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: The National CT Colonography Trial: Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population

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.

Read the 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.

Conditions: Colorectal Cancer
Being tested: CT Colonography
Keywords: colon cancer, rectal cancer
Medical subject headings: Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT ColonographyProcedure or surgery
Also called CT colonography trial, colonoscopy
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.

Study groups in NCT00084929
Study group	Role	What they receive
CT Colonography	Experimental	CT colonography conducted during the same assessment as colonoscopy. Receives: Procedure: CT Colonography

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: within 30 days
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)
Measured: 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)
Measured: within 30 days

Secondary outcomes (7)

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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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
Measured: at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 200513 May 2010

First posted11 Jun 2004 (estimated)
Study startFeb 2005
Primary completion11 Sep 2007
Study completion13 May 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00084929
Sponsor's protocol ID: CDR0000367101
Other IDs: ACRIN-6664, U01CA079778, U01CA080098
Acronym: ACRIN6664
Status last verified: Nov 2020
First submitted: 10 Jun 2004
Last updated: 22 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Researchers may request data from the ACRIN data access committee by reviewing the information at: https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

Publications

Vanness DJ, Knudsen AB, Lansdorp-Vogelaar I, Rutter CM, Gareen IF, Herman BA, Kuntz KM, Zauber AG, van Ballegooijen M, Feuer EJ, Chen MH, Johnson CD. Comparative economic evaluation of data from the ACRIN National CT Colonography Trial with three cancer intervention and surveillance modeling network microsimulations. Radiology. 2011 Nov;261(2):487-98. doi: 10.1148/radiol.11102411. Epub 2011 Aug 3.
PubMed 21813740
Johnson CD, Herman BA, Chen MH, Toledano AY, Heiken JP, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon R, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Blevins M, Burgart LJ, Limburg PJ, Gatsonis CA. The National CT Colonography Trial: assessment of accuracy in participants 65 years of age and older. Radiology. 2012 May;263(2):401-8. doi: 10.1148/radiol.12102177. Epub 2012 Feb 23.
PubMed 22361006
Hara AK, Blevins M, Chen MH, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Johnson CD. ACRIN CT colonography trial: does reader's preference for primary two-dimensional versus primary three-dimensional interpretation affect performance? Radiology. 2011 May;259(2):435-41. doi: 10.1148/radiol.11100250. Epub 2011 Mar 1.
PubMed 21364081
Hara AK, Kuo MD, Blevins M, Chen MH, Yee J, Dachman A, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Halvorsen RA Jr, Casola G, Johnson CD. National CT colonography trial (ACRIN 6664): comparison of three full-laxative bowel preparations in more than 2500 average-risk patients. AJR Am J Roentgenol. 2011 May;196(5):1076-82. doi: 10.2214/AJR.10.4334.
PubMed 21512073
Siewert B, Gareen I, Vanness D, et al.: ACRIN 6664: patient acceptance and preferance of CT colonography compared to optical colonoscopy for colon cancer screening. [Abstract] J Clin Oncol 27 (Suppl 15): A-4034, 2009.
Johnson CD, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Burgart LJ, Limburg PJ. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med. 2008 Sep 18;359(12):1207-17. doi: 10.1056/NEJMoa0800996.
PubMed 18799557

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The National CT Colonography Trial: Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population
ClinicalTrials.gov ID: NCT00084929
Acronym / sponsor ID: ACRIN6664 / CDR0000367101
Conditions: Colorectal Cancer
Keywords: colon cancer, rectal cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,600 participants (actual)
Lead sponsor: American College of Radiology Imaging NetworkResearch network
Collaborators: National Cancer Institute (NCI)
Study start: Feb 2005
Primary completion: 11 Sep 2007 (actual)
Study completion: 13 May 2010 (actual)
First posted: 11 Jun 2004 (estimated)
Results: Posted 16 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 are followed up for approximately 4 weeks.

PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CT Colonography	Experimental	Procedure: CT ColonographyCT colonography conducted during the same assessment as colonoscopy.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT ColonographyAlso: CT colonography trial, colonoscopyCT colonography performed for comparison with colonoscopy results performed during the same screening assessment.	Procedure or surgery	CT Colonography

Primary outcome

Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)

7 secondary outcomes

Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion)
Time frame: within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion)
Time frame: within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion)
Time frame: within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion)
Time frame: within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion)
Time frame: within 30 days
Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion)
Time frame: within 30 days
Interobserver Sensitivity Variability
Time frame: at baseline

Results and safety

Results posted to the registry on 16 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT Colonography	2,600	2,531

Primary outcome: Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient)

Time frame: within 30 days. Count of participants. Unit: Participants

Measure	CT Colonography n = 2531
RS+	109
RS-	2422

CT Colonography: Area Under the Curve (AUC): 0.89 (95% CI 0.853 to 0.933)
CT Colonography: Sensitivity: P(T+|D+): 0.9 (95% CI 0.838 to 0.96)
CT Colonography: P(T-|D-): 0.86 (95% CI 0.813 to 0.9)

Primary outcome: Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient)

Time frame: within 30 days. Count of participants. Unit: Participants

Measure	CT Colonography n = 2531
RS+: Advanced Adenoma >=9mm	120
RS-: Not Advanced Adenoma >=9mm	2411

CT Colonography: Area Under the Curve (AUC): 0.89 (95% CI 0.853 to 0.93)
CT Colonography: Sensitivity: P(T+|D+): 0.9 (95% CI 0.832 to 0.96)
CT Colonography: P(T-|D-): 0.86 (95% CI 0.817 to 0.902)

Primary outcome: Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient)

Time frame: within 30 days. Count of participants. Unit: Participants

Measure	CT Colonography n = 2531
RS+: Advanced Adenoma >=8mm	154
RS-: Not Advanced Adenoma >=8mm	2377

CT Colonography: Area Under the Curve (AUC): 0.88 (95% CI 0.842 to 0.913)
CT Colonography: Sensitivity: P(T+|D+): 0.87 (95% CI 0.803 to 0.929)
CT Colonography: P(T-|D-): 0.87 (95% CI 0.825 to 0.909)

Primary outcome: Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient)

Time frame: within 30 days. Count of participants. Unit: Participants

Measure	CT Colonography n = 2531
RS+: Advanced Adenoma >=7mm	174
RS-: Not Advanced Adenoma >=7mm	2357

CT Colonography: Area Under the Curve (AUC): 0.87 (95% CI 0.833 to 0.902)
CT Colonography: Sensitivity: P(T+|D+): 0.84 (95% CI 0.776 to 0.912)
CT Colonography: P(T-|D-): 0.87 (95% CI 0.831 to 0.914)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT Colonography	0 of 2,600 (0%)	0 of 2,600 (0%)	0 of 2,600
Colonoscopy	1 of 2,600 (0%)	0 of 2,600 (0%)	0 of 2,600

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21813740Vanness DJ, Knudsen AB, Lansdorp-Vogelaar I, Rutter CM, Gareen IF, Herman BA, Kuntz KM, Zauber AG, van Ballegooijen M, Feuer EJ, Chen MH, Johnson CD. Comparative economic evaluation of data from the ACRIN National CT Colonography Trial with three cancer intervention and surveillance modeling network microsimulations. Radiology. 2011 Nov;261(2):487-98. doi: 10.1148/radiol.11102411. Epub 2011 Aug 3.
Results publication: PubMed 22361006Johnson CD, Herman BA, Chen MH, Toledano AY, Heiken JP, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon R, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Blevins M, Burgart LJ, Limburg PJ, Gatsonis CA. The National CT Colonography Trial: assessment of accuracy in participants 65 years of age and older. Radiology. 2012 May;263(2):401-8. doi: 10.1148/radiol.12102177. Epub 2012 Feb 23.
Results publication: PubMed 21364081Hara AK, Blevins M, Chen MH, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Johnson CD. ACRIN CT colonography trial: does reader's preference for primary two-dimensional versus primary three-dimensional interpretation affect performance? Radiology. 2011 May;259(2):435-41. doi: 10.1148/radiol.11100250. Epub 2011 Mar 1.
Results publication: PubMed 21512073Hara AK, Kuo MD, Blevins M, Chen MH, Yee J, Dachman A, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Halvorsen RA Jr, Casola G, Johnson CD. National CT colonography trial (ACRIN 6664): comparison of three full-laxative bowel preparations in more than 2500 average-risk patients. AJR Am J Roentgenol. 2011 May;196(5):1076-82. doi: 10.2214/AJR.10.4334.
Results publicationSiewert B, Gareen I, Vanness D, et al.: ACRIN 6664: patient acceptance and preferance of CT colonography compared to optical colonoscopy for colon cancer screening. [Abstract] J Clin Oncol 27 (Suppl 15): A-4034, 2009.
Results publication: PubMed 18799557Johnson CD, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Burgart LJ, Limburg PJ. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med. 2008 Sep 18;359(12):1207-17. doi: 10.1056/NEJMoa0800996.
Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Researchers may request data from the ACRIN data access committee by reviewing the information at: https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

C. Daniel Johnson, MD study chair

Mayo Clinic

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CT Colonography in people with Colorectal Cancer, run by American College of Radiology Imaging Network at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient) (time frame: within 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00084929, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.