Localize Liver Metastases Clinical Trial
Official title:
A Pilot Study to Assess the Feasibility of Cone Beam CT to Localize Liver Metastases Immediately Prior to Radiotherapy
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.
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | October 2010 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 95 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |