Cone Beam Computed Tomography (CT) Bladder

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00913536
First received: June 2, 2009
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Bladder Cancer
Other: Using Cone beam CT in patients with Bladder Cancer

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cone-Beam Computed Tomography in Image-Guided Radiotherapy for Patients With Bladder Cancer

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2005
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cone beam CT in Bladder Cancer Other: Using Cone beam CT in patients with Bladder Cancer
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913536

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Peter Chung, MB ChB University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00913536     History of Changes
Other Study ID Numbers: UHN REB 05-0620-CE
Study First Received: June 2, 2009
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Bladder Cancer
Cone Beam CT
On-line image guidance
Radiation therapy in bladder cancer patients

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 15, 2014