Study of Breath-holding as a Means to Reduce Tumor Motion From Breathing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00178477
Recruitment Status : Terminated (Drs Okunieff and ODell have left the University of Rochester)
First Posted : September 15, 2005
Results First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Information provided by (Responsible Party):
University of Rochester

Brief Summary:
The purpose of this research study is to evaluate typical tumor motion caused by breathing using MRI and can help determine whether simple passive breathing and/or breath-holding could be used for the future treatment of similar lung and liver tumors using radiation therapy radiosurgery techniques.

Condition or disease Intervention/treatment Phase
Neoplasm, Metastatic Procedure: MRI with breath-holding Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study for Gated External-Beam Radiotherapy for Patients With Internal, Extra-cranial Tumors
Study Start Date : January 2002
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: Breath-holding
MRI with breath-holding
Procedure: MRI with breath-holding
Breath holding for diminished tumor motion.

Primary Outcome Measures :
  1. Tumor Motion Related to Breathing as Determined From MRI Images [ Time Frame: 20 - 30 seconds ]
    1. Determine the typical and maximal tumor 3D displacements over the respiratory cycle and how these values vary depending on the tumor location
    2. Determine the reproducibility of target position over multiple breath-holds
    3. Determine the variability across patients in respiratory-derived lesion motion and target position reproducibility over multiple breath-holds

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patient is enrolled on U8700 RSRB # A Phase II Study For Using Radiosurgery On Limited Metastases Of Breast Cancer or U9700 A Pilot Study For Using Radiosurgery On Limited Metastases.
  • ≥ 18 years of age
  • has given Informed consent

Exclusion Criteria:

-Contraindications for any MRI procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00178477

United States, New York
University of Rochester Department of Radiation Oncology
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: Walter O'Dell, PhD University of Rochester

Responsible Party: University of Rochester Identifier: NCT00178477     History of Changes
Other Study ID Numbers: URCC 3701
First Posted: September 15, 2005    Key Record Dates
Results First Posted: April 19, 2013
Last Update Posted: April 19, 2013
Last Verified: April 2013