Trial Outcomes & Findings for Study of Breath-holding as a Means to Reduce Tumor Motion From Breathing (NCT NCT00178477)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

20 - 30 seconds

Results posted on

2013-04-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Breath Hold MRI with Breath Hold
Overall Study STARTED	10
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=10 Participants MRI with Breath Hold
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 20 - 30 seconds

Population: Data were not analyzed due to study termination.

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

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Walter O'Dell, Ph.D.

University of Rochester Medical Center

Phone: 585-275-9996

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place