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Cone Beam Computed Tomography (CT) Bladder

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Using Cone beam CT in patients with Bladder Cancer
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder Cancer, Cone Beam CT, On-line image guidance, Radiation therapy in bladder cancer patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of carcinoma of the bladder

  • Patients undergoing radical external beam radiotherapy
  • Age >18 years
  • ECOG performance status 0-1
  • Informed consent

Exclusion Criteria:

  • Inflammatory bowel disease or collagen vascular disease
  • Patients undergoing palliative radiotherapy to the bladder

Sites / Locations

  • University Health Network, Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cone beam CT in Bladder Cancer

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving radiation therapy for bladder cancer.

Secondary Outcome Measures

Measure interfraction,intrafraction & deformity of bladder;determine adequacy of present margins; report bladder volume changes during treatment; evaluate use of fiducial markers plus CBCT for on-line image guidance & transabdominal ultrasound system.

Full Information

First Posted
June 2, 2009
Last Updated
April 24, 2019
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00913536
Brief Title
Cone Beam Computed Tomography (CT) Bladder
Official Title
Cone-Beam Computed Tomography in Image-Guided Radiotherapy for Patients With Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2005 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
October 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to investigate whether daily images of the pelvis and bladder using a device called a cone beam CT scanner will help to increase the accuracy of radiotherapy treatment. The cone beam CT scanner is a part of the radiotherapy treatment unit. The results of the study may allow patients in the future who are undergoing radiotherapy treatment for bladder cancer to 1) have more accurately directed treatment, 2) have higher doses of radiation delivered to the tumour while keeping doses to the surrounding normal tissues as low as possible. This may allow eradication of the cancer while minimizing side effects of treatment. This study consists of two phases: Phase A and Phase B. In Phase A, images were collected and analyzed and it was confirmed that it was useful to use the cone beam machine for daily Cone Beam CT Bladder (Phase B)treatment adjustments. In phase B, we hope to be able to use cone beam CT scans to more accurately direct the radiotherapy treatments on a daily basis.
Detailed Description
Cone beam computed tomography (CT) is new technology that allows the acquisition of 3-dimensional cross-sectional imaging while the patient is positioned on a linear accelerator couch. Cone beam CT also provides 3D soft tissue volumetric data and therefore important information on daily interfraction movement and deformation of normal critical structures within the pelvis. Visualization of the tumor using this technology may also be enhanced by the additional placement of fiducial markers around the tumor bed to ensure even more accurate targeting. The aim of this study is to assess the feasibility of daily cone beam CT for image guidance in patients receiving radiation therapy (RT) for bladder cancer as well document changes in size and location of the bladder and rectum during an entire course of RT. This will enable us to explore techniques for radiation therapy based on normal tissue avoidance models to reduce treatment toxicity and potentially dose escalation in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Bladder Cancer, Cone Beam CT, On-line image guidance, Radiation therapy in bladder cancer patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cone beam CT in Bladder Cancer
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Using Cone beam CT in patients with Bladder Cancer
Intervention Description
Using cone beam CT scanner will help to increase the accuracy of your radiotherapy treatment. The cone beam CT scanner is a part of the radiotherapy treatment unit.
Primary Outcome Measure Information:
Title
To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving radiation therapy for bladder cancer.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Measure interfraction,intrafraction & deformity of bladder;determine adequacy of present margins; report bladder volume changes during treatment; evaluate use of fiducial markers plus CBCT for on-line image guidance & transabdominal ultrasound system.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of carcinoma of the bladder Patients undergoing radical external beam radiotherapy Age >18 years ECOG performance status 0-1 Informed consent Exclusion Criteria: Inflammatory bowel disease or collagen vascular disease Patients undergoing palliative radiotherapy to the bladder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Chung, MB ChB
Organizational Affiliation
University Health Network, Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Cone Beam Computed Tomography (CT) Bladder

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