Study of Breath-holding as a Means to Reduce Tumor Motion... | NCT00178477

NCT00178477

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Breath-holding	Experimental	MRI with breath-holding	Procedure: MRI with breath-holding

Name	Type	Description	Arm Group Labels	Other Names
MRI with breath-holding	Procedure	Breath holding for diminished tumor motion.	Breath-holding

Outcomes Module

Primary Outcomes

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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Walter O'Dell, PhD	University of Rochester	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester Department of Radiation Oncology		Rochester	New York	14642	United States

ID	Title	Description
FG000	Breath Hold	MRI with Breath Hold

Baseline Characteristics Module

ID	Title	Description
BG000	Group 1	MRI with Breath Hold

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Tumor Motion Related to Breathing as Determined From MRI Images

Determine the typical and maximal tumor 3D displacements over the respiratory cycle and how these values vary depending on the tumor location
Determine the reproducibility of target position over multiple breath-holds
Determine the variability across patients in respiratory-derived lesion motion and target position reproducibility over multiple breath-holds

Data were not analyzed due to study termination.

Posted

20 - 30 seconds

ID	Title	Description
OG000	Group 1	MRI with Breath Hold

Units	Counts
Participants

Adverse Events Module

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1	MRI with Breath Hold

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Walter O'Dell, Ph.D.	University of Rochester Medical Center	585-275-9996		walter_odell@urmc.rochester.edu

Condition Browse Module

ID	Term
D009362	Neoplasm Metastasis

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Intervention Browse Module

ID	Term
D009682	Magnetic Resonance Spectroscopy
D062485	Breath Holding

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D012119	Respiration