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CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585728
First received: December 21, 2007
Last updated: August 26, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Rectal Cancer
 Procedure: CT Virtual Proctoscopy (CTVP)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
CT virtual proctoscopy
 Procedure: CT Virtual Proctoscopy (CTVP)
CTVP done prior to initiation of therapy and a couple of weeks before patient has surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585728

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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585728     History of Changes
Other Study ID Numbers: 2007-0134 (CC07206)
Study First Received: December 21, 2007
Last Updated: August 26, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013