Clinical trial NCT00084929: The National CT Colonography Trial
Official title: The National CT Colonography Trial: Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colon cancer
rectal cancer
Lead sponsor: American College of Radiology Imaging Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-11
Enrollment: 2600
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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)

Primary outcomes:
measure: Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient)
timeFrame: within 30 days
measure: Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient)
timeFrame: within 30 days
measure: Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient)
timeFrame: within 30 days
measure: Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient)
timeFrame: within 30 days
measure: Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient)
timeFrame: within 30 days
measure: Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient)
timeFrame: within 30 days
Secondary outcomes:
measure: Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion)
timeFrame: within 30 days
measure: Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion)
timeFrame: within 30 days
measure: Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion)
timeFrame: within 30 days
measure: Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion)
timeFrame: within 30 days
measure: Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion)
timeFrame: within 30 days
measure: Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion)
timeFrame: within 30 days
measure: Interobserver Sensitivity Variability
timeFrame: at baseline
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
city: San Francisco
country: United States
facility: Veterans Affairs Medical Center - San Francisco
state: California
city: Englewood
country: United States
facility: Invision/Radiology Imaging Associates - Englewood
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Springfield
country: United States
facility: Clinical Radiologists, S.C. at Memorial Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Louis
country: United States
facility: Mallinckrodt Institute of Radiology at Washington University Medical Center
state: Missouri
city: Houston
country: United States
facility: M.D. Anderson Cancer Center at University of Texas
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Massey Cancer Center
state: Virginia
Study officials:
affiliation: Mayo Clinic
name: C. Daniel Johnson, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.