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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00722605
First received: July 23, 2008
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Lung Cancer
 Procedure: cone-beam CT
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Use of Multiple Respiration-Correlated Cone Beam CT Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: July 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722605

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Andreas Rimner, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00722605     History of Changes
Other Study ID Numbers: 08-080
Study First Received: July 23, 2008
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
lung
esophageal
cone beam ct scan

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Lung Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013