CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00585728
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 47
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Procedure: CT Virtual Proctoscopy (CTVP)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• 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: Sep 1, 2007
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

1. The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer. [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00585728
• Other Study ID Numbers: 2007-0134 (CC07206); A534260; SMPH\MEDICINE\HEM-ONC; 2007-0134
• First Posted: Jan 3, 2008
• Last Update Posted: Dec 13, 2019
• Last Verified: Aug 1, 2011

• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Dec 13, 2019