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

Study Overview
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Brief Summary
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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.

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

Conditions
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Localize Liver Metastases

Intervention / Treatment
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* Radiation: cone beam imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients going for treatment of liver metastases with radiation therapy. | Radiation: cone beam imaging<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Eligible for Cone Beam Tumor Localization | Assess the feasibility of using a new imaging technique called cone beam imaging to localize a liver tumor immediately prior to external beam radiotherapy. | Up to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation Therapy