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CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer

NCT ID: NCT00585728

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

CT virtual proctoscopy

Group Type OTHER

CT Virtual Proctoscopy (CTVP)

Intervention Type PROCEDURE

CTVP done prior to initiation of therapy and a couple of weeks before patient has surgery.

Interventions

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CT Virtual Proctoscopy (CTVP)

CTVP done prior to initiation of therapy and a couple of weeks before patient has surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles P Heise, M.D.

Role: PRINCIPAL_INVESTIGATOR

UW Hospital & Clinics, Department of Surgery

Locations

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University of Wisconsin Hospital & Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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A534260

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\HEM-ONC

Identifier Type: OTHER

Identifier Source: secondary_id

2007-0134

Identifier Type: OTHER

Identifier Source: secondary_id

2007-0134 (CC07206)

Identifier Type: -

Identifier Source: org_study_id