Back to resultsCT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT Virtual Proctoscopy (CTVP)
Sponsored by
About this trial
This is an interventional diagnostic trial for Rectal Cancer
Eligibility 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
Sites / Locations
- University of Wisconsin Hospital & Clinics
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
CT virtual proctoscopy
Outcomes
Primary Outcome Measures
The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer.
Secondary Outcome Measures
Full Information
NCT ID
NCT00585728
First Posted
December 21, 2007
Last Updated
December 12, 2019
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00585728
Brief Title
CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer
Official Title
CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
CT virtual proctoscopy
Intervention Type
Procedure
Intervention Name(s)
CT Virtual Proctoscopy (CTVP)
Intervention Description
CTVP done prior to initiation of therapy and a couple of weeks before patient has surgery.
Primary Outcome Measure Information:
Title
The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles P Heise, M.D.
Organizational Affiliation
UW Hospital & Clinics, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital & Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer
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