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

Primary Purpose

Localize Liver Metastases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cone beam imaging
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Localize Liver Metastases focused on measuring Radiation Therapy

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Patients going for treatment of liver metastases with radiation therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2008
Last Updated
April 17, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00600613
Brief Title
Assess the Feasibility of Cone Beam CT to Localize Liver Metastases Immediately Prior to Radiotherapy
Official Title
A Pilot Study to Assess the Feasibility of Cone Beam CT to Localize Liver Metastases Immediately Prior to Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localize Liver Metastases
Keywords
Radiation Therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients going for treatment of liver metastases with radiation therapy.
Intervention Type
Radiation
Intervention Name(s)
cone beam imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Eligible for Cone Beam Tumor Localization"
Description
Assess the feasibility of using a new imaging technique called "cone beam imaging" to localize a liver tumor immediately prior to external beam radiotherapy.
Time Frame
Up to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiya Yamada, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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