Clinical trial NCT00586053: Unprepped CT Colonography
Official title: "CTC of the Unprepped Colon: Optimization & Validation"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: Colonic Polyps
Colon
Large Intestine
Cecum
Sigmoid
Rectum
Colonoscopy
Virtual Colonoscopy
CT Colonography
Computed Tomographic Colonography
Colonography
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-04
Enrollment: 1255
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mayo Clinic patients scheduled for colonoscopy.

Brief summary: It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening test.

Detailed description: To improve the diagnostic performance of CTC in the prepared colon using improved spatial resolution, advanced image displays, and computer-assisted diagnosis, and to optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques. To estimate the sensitivity and specificity of CTC in the unprepared colon for clinically important colorectal neoplasms (large adenomas ≥ 1 cm) and to compare such estimates with colonoscopy. To survey patient acceptance of CTC in the unprepared colon, and to assess implications for health care costs and cost-effectiveness of CTC in the unprepared colon in comparison with other approaches.

Eligibility criteria: Inclusion Criteria:

Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications:

* Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.
* Age ≥ 40 -100 years
* Known or highly suspected primary colorectal neoplasms \> 10 mm (n = 160)
* Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.

Exclusion Criteria:

* Less than 1/2 of colorectum remaining
* Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis)
* Familial Polyposis
* Melena, hematochezia

Primary outcomes:
measure: To optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques.
timeFrame: 2000-2009
Secondary outcomes:
measure: The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening tests
timeFrame: 2000-2009
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: C. Daniel Johnson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacCarty RL, Johnson CD, Fletcher JG, Wilson LA. Occult colorectal polyps on CT colonography: implications for surveillance. AJR Am J Roentgenol. 2006 May;186(5):1380-3. doi: 10.2214/AJR.05.0031.
citation: Johnson CD, Fletcher JG, MacCarty RL, Mandrekar JN, Harmsen WS, Limburg PJ, Wilson LA. Effect of slice thickness and primary 2D versus 3D virtual dissection on colorectal lesion detection at CT colonography in 452 asymptomatic adults. AJR Am J Roentgenol. 2007 Sep;189(3):672-80. doi: 10.2214/AJR.07.2354.