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

This study has been terminated.
(Drs Okunieff and ODell have left the University of Rochester)
Sponsor:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178477
First received: September 13, 2005
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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 Intervention
Neoplasm, Metastatic
Procedure: MRI with breath-holding

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study for Gated External-Beam Radiotherapy for Patients With Internal, Extra-cranial Tumors

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Tumor Motion Related to Breathing as Determined From MRI Images [ Time Frame: 20 - 30 seconds ] [ Designated as safety issue: No ]
    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


Enrollment: 10
Study Start Date: January 2002
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breath-holding
MRI with breath-holding
Procedure: MRI with breath-holding
Breath holding for diminished tumor motion.

  Eligibility

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178477

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

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00178477     History of Changes
Other Study ID Numbers: URCC 3701
Study First Received: September 13, 2005
Results First Received: August 12, 2011
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Second Primary

ClinicalTrials.gov processed this record on July 22, 2014