The Use of Breathing Synchronized CT and PET Scans in Radiation Therapy Treatment Planning

December 23, 2015 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: PET/CT scan
PET/CT scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kenneth Rosenzweig, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 8, 2008

Study Record Updates

Last Update Posted (Estimate)

December 24, 2015

Last Update Submitted That Met QC Criteria

December 23, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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