NCT00913536

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2005

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

November 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2018

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

12.8 years

First QC Date

June 2, 2009

Last Update Submit

April 24, 2019

Conditions

Keywords

Bladder CancerCone Beam CTOn-line image guidanceRadiation therapy in bladder cancer patients

Outcome Measures

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.

    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.

    5 years

Study Arms (1)

Cone beam CT in Bladder Cancer

EXPERIMENTAL
Other: Using Cone beam CT in patients with Bladder Cancer

Interventions

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.

Cone beam CT in Bladder Cancer

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of carcinoma of the bladder
  • Patients undergoing radical external beam radiotherapy
  • Age \>18 years
  • ECOG performance status 0-1
  • Informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Peter Chung, MB ChB

    University Health Network, Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 4, 2009

Study Start

November 1, 2005

Primary Completion

September 1, 2018

Study Completion

October 11, 2018

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations