NCT00923871

Brief Summary

Breast radiation treatment is planned from a Computed Tomography (CT) scan. This study is designed to investigate a method to reduce the time between the planning of radiation treatment and its actual start by automating the intensity-modulated radiation therapy (IMRT) planning process. The investigators plan to examine data from another scan called Cone Beam Computed Tomography (CBCT). A CBCT scan provides similar information to a conventional CT scan, however the images for CBCT are acquired at the treatment unit (linear accelerator used for treatment). Using these x-ray pictures of patients, the study team consisting of a radiation oncologist, a medical physicist and a radiation therapist will create a custom treatment plan unique to each patient. By doing this, the investigators hope to reduce the amount of time spent waiting for treatment and the number of hospital visits for patients in the future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable breast-cancer

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

June 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2016

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

5.6 years

First QC Date

June 16, 2009

Last Update Submit

October 17, 2022

Conditions

Keywords

CBCTBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • To generate on-line IMRT treatment plans using automated tools based on CBCT images acquired at the treatment unit.

    3 years

Study Arms (1)

Cone Beam CT

EXPERIMENTAL
Procedure: Cone Beam CT

Interventions

Cone Beam CTPROCEDURE

Patients will also have a CBCT scan when they are having their first IMRT treatment.

Cone Beam CT

Eligibility Criteria

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

You may qualify if:

  • Patients with breast cancer who will receive standard two-field tangential whole breast radiation therapy with dose prescription of 4240 cGy in 16 fractions, 5000 cGy in 25 fractions or 4000 cGy in 16 fractions.
  • Patients with any stage of breast cancer.
  • Patients with prior treatment such as surgery or chemotherapy for any type of cancer.
  • Able to provide a written informed consent.
  • years of age or older.

You may not qualify if:

  • \< 18 years of age.
  • Unable to provide informed consent.
  • Males.
  • Patients who received partial breast radiation and not the standard dose.
  • Patients who will not receive 4240 cGy in 16 fractions, 5000 cGy in 25 fractions, or 4000 cGy in 16 fractions.

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

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anne Koch, MD

    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 16, 2009

First Posted

June 18, 2009

Study Start

June 1, 2009

Primary Completion

January 5, 2015

Study Completion

April 29, 2016

Last Updated

October 18, 2022

Record last verified: 2022-10

Locations