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Computerized Tomographic Colonography: Performance Evaluation in a Multicenter Setting


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Computerized Tomographic Colonography: Performance Evaluation in a Multicenter Setting


OBJECTIVES: I. Compare retrospectively the accuracy of computerized tomographic colonography
(CTC) vs pathology and colonoscopy in the detection of clinically important colorectal
neoplasia, defined as at least one proven lesion with a diameter measuring at least 1 cm.
II. Compare the physician image display preferences and interpretation time across three
viewing platforms for CTC images.

OUTLINE: This is a retrospective, multicenter study. Radiologists evaluate each patient's
optimal diagnostic computerized tomographic colonography (CTC) data. Patients' CTC findings
are evaluated by a radiologist at a central facility using an imaging display software
platform from General Electric, Vital Images, or the Mayo Clinic. CTC findings are compared
with conventional colonoscopy findings and pathologic analysis. A comparison is made between
physician image display preferences and interpretation time across three viewing platforms
for CTC images.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: The following case material must be submitted for each patient:
No colonic diseases except polyps, cancer, or diverticulosis Optimal diagnostic
computerized tomographic colonography (CTC) data with computed tomography acquisition
parameters that meet the following minimal standards: Slice thickness no greater than 5 mm
Reconstruction interval no greater than 3 mm Pitch no greater than 2 Anatomic coverage of
the entire colorectum Supine and prone data sets Complete colonoscopy performed within 30
days following CTC by a board certified gastroenterologist or a physician with at least 3
years of colonoscopic experience Pathology reports for all endoscopically or surgically
removed colorectal lesions with the exception of polyps that are inadvertently dropped at
the time of retrieval Photograph or videotape record of dropped lesion allowed as proof of
its existence All studies are allowed including those with lesions less than 1 cm, lesions
at least 1 cm, or no lesions Report documents size, site, stage, grade, and type of
colorectal cancers; size, site, degree of dysplasia, and type of colorectal adenomas; and
types of other lesions (e.g., inflammatory, vascular, ulcerative) Demographic data
including patient's age, sex, ethnic background, symptoms, risk factors, and relevant
clinical history

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

C. Daniel Johnson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000067802

NCT ID:

NCT00005809

Start Date:

July 2000

Completion Date:

January 2003

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colorectal Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Mallinckrodt Institute of RadiologySaint Louis, Missouri  63110
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Emory University School of MedicineAtlanta, Georgia  30322