NCT00178477

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

April 19, 2013

Completed
Last Updated

April 19, 2013

Status Verified

April 1, 2013

Enrollment Period

9 years

First QC Date

September 13, 2005

Results QC Date

August 12, 2011

Last Update Submit

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

EXPERIMENTAL

MRI with breath-holding

Procedure: MRI with breath-holding

Interventions

Breath holding for diminished tumor motion.

Breath-holding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Magnetic Resonance SpectroscopyBreath Holding

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Results Point of Contact

Title
Walter O'Dell, Ph.D.
Organization
University of Rochester Medical Center

Study Officials

  • Walter O'Dell, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

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

Locations