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

Results First Received: August 12, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Neoplasm, Metastatic
Intervention:	Procedure: MRI with breath-holding

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects will be identified from patients seen in the Department of Radiation Oncology and who have previously consented to participate in URCC 8700 or URCC 9700.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Breath Hold	MRI with Breath Hold

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Group 1	MRI with Breath Hold

Baseline Measures

	Group 1
Number of Participants [units: participants]	10
Age [units: participants]
<=18 years	0
Between 18 and 65 years	10
>=65 years	0
Gender [units: participants]
Female	6
Male	4
Region of Enrollment [units: participants]
United States	10

Outcome Measures

1. Primary:

Tumor Motion Related to Breathing as Determined From MRI Images [ Time Frame: 20 - 30 seconds ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Walter O'Dell, Ph.D.
Organization: University of Rochester Medical Center
phone: 585-275-9996
e-mail: walter_odell@urmc.rochester.edu

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