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Clinical Trials/NCT00600613
NCT00600613
Completed
Not Applicable

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

Memorial Sloan Kettering Cancer Center1 site in 1 country6 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Localize Liver Metastases
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
6
Locations
1
Primary Endpoint
Number of Participants Eligible for Cone Beam Tumor Localization"
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
October 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.
  • Marker seed placement not possible
  • \> 5mm excursion after abdominal compression

Outcomes

Primary Outcomes

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.

Study Sites (1)

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