CT Virtual Proctoscopy for Staging and Volume Assessment... | NCT00585728

Studies
CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer

NCT00585728

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Dec 13, 2019Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Rectal Cancer

Interventions

CT Virtual Proctoscopy (CTVP)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
A534260	Other Identifier	UW Madison
SMPH\MEDICINE\HEM-ONC	Other Identifier	UW Madison
2007-0134	Other Identifier	Institutional Review Board

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Dec 21, 2007

First Posted Date

Jan 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2019

Last Update Posted Date

Dec 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	CT virtual proctoscopy	Procedure: CT Virtual Proctoscopy (CTVP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT Virtual Proctoscopy (CTVP)	Procedure	CTVP done prior to initiation of therapy and a couple of weeks before patient has surgery.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer.		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles P Heise, M.D.	UW Hospital & Clinics, Department of Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin Hospital & Clinics		Madison	Wisconsin	53792	United States

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided