The Use of Breathing Synchronized CT and PET Scans in Radiation Therapy Treatment Planning
Primary Purpose
Lung Cancer, Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PET/CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- Ability to sign informed consent form indicating investigative nature of this study, in keeping with the policies of the hospital.
- Patients must have thoracic disease visible on a Chest CT scan, or liver disease visible on a abdominal CT scan.
Exclusion Criteria:
- Pregnant women are ineligible. A pregnancy test will be performed on each fertile premenopausal female prior to entry into the study.
- Patients with thoracic or liver disease that is not visible on CT scan
- Patients who are unable to follow directions either due to language difficulties or hearing impairment.
- Patients who are too ill to hold their breath.
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
To measure the amount of tumor motion in breathing synchronized CT scans and determine the fraction of patients whose radiation treatment planning margins would be modified based on this information.
Secondary Outcome Measures
To measure changes in tumor definition with breathing synchronized PET compared to standard free breathing PET, and determine the fraction of patients whose radiation treatment plans would be modified based on this information.
Full Information
NCT ID
NCT00588328
First Posted
December 20, 2007
Last Updated
December 23, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00588328
Brief Title
The Use of Breathing Synchronized CT and PET Scans in Radiation Therapy Treatment Planning
Official Title
The Use of Breathing Synchronized CT and PET Scans in Radiation Therapy Treatment Planning
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to find out whether a new device can help obtain more accurate CT and PET scans of the lungs and chest tumors and the liver and liver tumors to help in delivering radiation therapy. When we breathe, the amount of air in the lung changes. Lung tumors may also move during breathing. Liver tumors may also move with breathing; as the lungs inflate, the liver can be pushed down. A CT scan (a special type of X-ray) is routinely obtained as part of planning for lung or liver radiation therapy. Since patients breathe during this CT scan and their lung or liver tumors move, these CT scans can sometimes be inaccurate. We are now testing a device to only obtain the CT and an additional PET scan while patients are breathing in or out. This will hopefully allow us to deliver radiation with more accuracy.
Detailed Description
The objectives are to measure the amount of tumor motion with respiration, measure changes in tumor definition with breathing synchronized PET compared to standard free breathing PET, and to determine the fraction of patients whose radiation treatment plans would be modified based on this information. Eligible patients are those receiving radiation treatment for thoracic or liver tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PET/CT scan
Intervention Description
PET/CT scans
Primary Outcome Measure Information:
Title
To measure the amount of tumor motion in breathing synchronized CT scans and determine the fraction of patients whose radiation treatment planning margins would be modified based on this information.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To measure changes in tumor definition with breathing synchronized PET compared to standard free breathing PET, and determine the fraction of patients whose radiation treatment plans would be modified based on this information.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old
Ability to sign informed consent form indicating investigative nature of this study, in keeping with the policies of the hospital.
Patients must have thoracic disease visible on a Chest CT scan, or liver disease visible on a abdominal CT scan.
Exclusion Criteria:
Pregnant women are ineligible. A pregnancy test will be performed on each fertile premenopausal female prior to entry into the study.
Patients with thoracic or liver disease that is not visible on CT scan
Patients who are unable to follow directions either due to language difficulties or hearing impairment.
Patients who are too ill to hold their breath.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Rosenzweig, 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
Related Info
Learn more about this trial
The Use of Breathing Synchronized CT and PET Scans in Radiation Therapy Treatment Planning
We'll reach out to this number within 24 hrs