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

Not Applicable

Completed

• Conditions: Localize Liver Metastases
• Interventions: Radiation: cone beam imaging

• Registration Number: NCT00600613
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-25
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2015-04
• Results First Submitted: 2015-04-07
• Results First Submitted QC: 2015-04-07
• Results First Posted: 2015-04-17
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	cone beam imaging	Patients going for treatment of liver metastases with radiation therapy.

Primary Outcome Measures

Name	Time	Method
Number of Participants Eligible for Cone Beam Tumor Localization"	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States