Multiple Respiration-Correlated Cone Beam Computed Tomography (CT) Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer

January 23, 2013 updated by: Memorial Sloan Kettering Cancer Center

The Use of Multiple Respiration-Correlated Cone Beam CT Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer.

The purpose of this study is to use cone-beam CT scans to more accurately position the tumor during radiation and to see whether this method is more effective than the standard method of using 2D images (portal images), which is a type of X-ray. Cone-beam CT is a type of CT scanner attached to the treatment accelerator that produces 3D images of the patient.

The ability to eliminate the tumor with radiation depends in part on the accuracy of delivering the radiation to the lung. The position of the tumor changes because of normal breathing. Therefore, we want to improve the accuracy of the way the radiation is delivered to the tumor. With cone-beam CT scans taken before and during your treatment, we will be able to determine the location of the tumor with 3D images, measure how much the tumor moves as you breathe, and then position you so that the tumor will get the best delivery of radiation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have histologic proof of a thoracic malignancy, confirmed at MSKCC and suitable for radiation therapy, in order to be eligible for this study.
  • Patients must be older than 18 years of age
  • At least part of the tumor must be visible as observed in a diagnostic or planning CT. Patients must have Karnofsky Performance Status ≥ 70%

Exclusion Criteria:

  • Pregnant Women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
cone-beam CT based
Procedure: cone-beam CT

You will have the following CT scans along with the standard weekly portal images:Before treatment you will have a CT scan (a respiratory-correlated CT scan) at the time of the radiation planning, or simulation planning.During the first week of treatment - you will have 5 cone-beam CT scans at days 1 through 5 of your radiation treatment schedule.

  • During the remaining weeks of treatment - you will have a cone-beam CT scan every week. Depending on the number of treatments that your study doctor has prescribed for you, the number of weekly scans can be between 3 and 7.
  • For all scans, an external monitor will be used to record your breathing.
  • If needed, you will be repositioned by adjusting the radiation machine's treatment couch position.
Other Names:
  • The total number of cone-beam CT scans can be between 8 and 10. The scans will take about 15
  • minutes and will occur before your treatment. The scans will help determine whether the
  • radiation is being delivered accurately to the tumor and whether adjustments need to be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To enhance the accuracy of treatment delivery by using a cone-beam CT guided patient positioning procedure, relative to the standard portal image guided procedure.
Time Frame: conclusion of the study
conclusion of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the reduction in the proportion of patients with large target positioning errors using the cone-beam CT guided procedure.
Time Frame: conclusion of the study
conclusion of the study
To gather data on organ motion and setup errors in the thorax and how they vary over the treatment course, in order to develop efficient clinical correction strategies.
Time Frame: conclusion of the study
conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 24, 2008

First Posted (Estimate)

July 25, 2008

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08-080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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