CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00585728
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : August 30, 2011
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of this study is to see how CT virtual proctoscopy compares to an ultrasound exam of the rectal area in determining the stage of rectal cancer for people recently diagnosed with rectal cancer. This study will also compare tumor volume before and after neoadjuvant therapy using CT virtual proctoscopy, with the ultrasound exam as a comparison. Neoadjuvant therapy consists of chemotherapy and radiation therapy. Neoadjuvant chemoradiation therapy is done before surgery to reduce the size of tumors.

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: CT Virtual Proctoscopy (CTVP) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer
Study Start Date : September 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
CT virtual proctoscopy
Procedure: CT Virtual Proctoscopy (CTVP)
CTVP done prior to initiation of therapy and a couple of weeks before patient has surgery.

Primary Outcome Measures :
  1. The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have been diagnosed with adenocarcinoma of the rectum, who have not started their neoadjuvant treatment yet.

Exclusion Criteria:

  • Patients who have started their neoadjuvant therapy already

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00585728

United States, Wisconsin
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Charles P Heise, M.D. UW Hospital & Clinics, Department of Surgery

Responsible Party: University of Wisconsin, Madison Identifier: NCT00585728     History of Changes
Other Study ID Numbers: 2007-0134 (CC07206)
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases