NCT00585728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 13, 2019

Status Verified

August 1, 2011

Enrollment Period

3.9 years

First QC Date

December 21, 2007

Last Update Submit

December 12, 2019

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer.

    3 months

Study Arms (1)

1

OTHER

CT virtual proctoscopy

Procedure: CT Virtual Proctoscopy (CTVP)

Interventions

CT Virtual Proctoscopy (CTVP)PROCEDURE

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who have started their neoadjuvant therapy already

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Charles P Heise, M.D.

    UW Hospital & Clinics, Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 3, 2008

Study Start

September 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 13, 2019

Record last verified: 2011-08

Locations

US(1)