The Use of Breathing Synchronized CT and PET Scans in Radiation Therapy Treatment Planning - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00588328

Purpose

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.

Condition	Intervention
Lung Cancer Non-Hodgkin's Lymphoma	Device: PET/CT scan

MedlinePlus related topics: CT Scans Cancer Lung Cancer Lymphoma Nuclear Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	The Use of Breathing Synchronized CT and PET Scans in Radiation Therapy Treatment Planning

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	March 2000
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: PET/CT scan PET/CT scans

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588328

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Kenneth Rosenzweig, MD

Memorial Sloan-Kettering Cancer Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Kenneth, Rosenzweig, MD )
Study ID Numbers:	00-008
Study First Received:	December 20, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00588328
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009