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Assess the Feasibility of Cone Beam CT to Localize Liver Metastases Immediately Prior to Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00600613
Recruitment Status : Completed
First Posted : January 25, 2008
Results First Posted : April 17, 2015
Last Update Posted : May 7, 2015
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:

The purpose of this study is to test a new and possibly more accurate method of positioning patients with liver tumors in preparation for radiation treatment.

The positioning of patients with liver cancer is important because the tumor moves a bit when you breathe and makes it hard to determine the right position of the tumor at the time of treatment. Also, depending upon what is in your stomach at the time of treatment, it may change the shape of the liver and make it difficult to plan the radiation treatment. As part of this study, we will take a new type of image of your liver in addition to the standard portal images. This new type of image is called a cone-beam image. It shows a much more detailed picture of the liver tumors than the standard portal images. Normally, marker seeds need to be placed near the liver metastasis for radiation treatment. If the results of this study show that the tumor can be positioned as accurately with the new images as with the old images, then future patients with liver tumors would not have to have marker seeds placed into their liver. The use of cone beam imaging for the setup of patients with liver tumors is new.


Condition or disease Intervention/treatment Phase
Localize Liver Metastases Radiation: cone beam imaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Assess the Feasibility of Cone Beam CT to Localize Liver Metastases Immediately Prior to Radiotherapy
Study Start Date : January 2006
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Patients going for treatment of liver metastases with radiation therapy.
 Radiation: cone beam imaging
All study patients will undergo simulation, treatment planning and verification as currently practiced. The contrast injection and cone beam imaging will be added to the standard procedure just prior to treatment delivery on the first and last days of treatment only.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Eligible for Cone Beam Tumor Localization" [ Time Frame: Up to 2 hours ]
    Assess the feasibility of using a new imaging technique called "cone beam imaging" to localize a liver tumor immediately prior to external beam radiotherapy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > than or equal to 18 years
  • KPS > than or equal to 80
  • Able to tolerate immobilization cradle positioning
  • Able to give informed consent
  • Histologically confirmed diagnosis of solid tumor malignancy
  • Liver metastases visualized on CT imaging

Exclusion Criteria:

  • Lymphoid primary histology (lymphoma/leukemia)
  • Allergic reaction to intravenous CT contrast
  • Liver function tests (AST, ALT, Bilirubin) > 2.0 x normal
  • Abnormal kidney function (serum creatinine > 1.5)
  • INR > 2.0, Platelet count <70.000.
  • Marker seed placement not possible
  • > 5mm excursion after abdominal compression
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600613


Locations
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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
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Principal Investigator: Yoshiya Yamada, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00600613    
Other Study ID Numbers: 05-129
First Posted: January 25, 2008    Key Record Dates
Results First Posted: April 17, 2015
Last Update Posted: May 7, 2015
Last Verified: April 2015
Keywords provided by Memorial Sloan Kettering Cancer Center:
Radiation Therapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases