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

NCT ID: NCT00600613

Last Updated: 2015-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-10-31

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.

Conditions

Localize Liver Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Patients going for treatment of liver metastases with radiation therapy.

Group Type: EXPERIMENTAL

cone beam imaging

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

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 <70.000.
• Marker seed placement not possible
• > 5mm excursion after abdominal compression

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoshiya Yamada, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

05-129

Identifier Type: -

Identifier Source: org_study_id