Skip to main content
OpenTrials
Completed

NCT Number: NCT00913536

Cone Beam Computed Tomography (CT) Bladder

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Using Cone beam CT in patients with Bladder Cancer

Other

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 outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

Cone-Beam Computed Tomography in Image-Guided Radiotherapy for Patients With Bladder Cancer

Important dates

Study start
2005
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2009
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.