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

NCT00600613 | Completed Results

• 1 other identifier: 05-129
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

Patients going for treatment of liver metastases with radiation therapy.

Radiation: cone beam imaging

Interventions

cone beam imaging 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.

1

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Results Point of Contact

• Title: Dr. Yoshiya Yamada
• Organization: Memorial Sloan Kettering Cancer Center

yamadaj@mskcc.org

212-639-2950

Study Officials

• Yoshiya Yamada, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: January 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 7, 2015
• Results First Posted: April 17, 2015

Record last verified: 2015-04

Locations

US (1)