Study Stopped
Drs Okunieff and ODell have left the University of Rochester
Study of Breath-holding as a Means to Reduce Tumor Motion From Breathing
Feasibility Study for Gated External-Beam Radiotherapy for Patients With Internal, Extra-cranial Tumors
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
April 19, 2013
CompletedApril 19, 2013
April 1, 2013
9 years
September 13, 2005
August 12, 2011
April 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Tumor Motion Related to Breathing as Determined From MRI Images
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
20 - 30 seconds
Study Arms (1)
Breath-holding
EXPERIMENTALMRI with breath-holding
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindications for any MRI procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester Department of Radiation Oncology
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Walter O'Dell, Ph.D.
- Organization
- University of Rochester Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Walter O'Dell, PhD
University of Rochester
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
January 1, 2002
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
April 19, 2013
Results First Posted
April 19, 2013
Record last verified: 2013-04