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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00178477
Enrollment
10
Registered
2005-09-15
Start date
2002-01-31
Completion date
2011-01-31
Last updated
2013-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm, Metastatic

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.

Interventions

PROCEDUREMRI with breath-holding

Breath holding for diminished tumor motion.

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

-Contraindications for any MRI procedure

Design outcomes

Primary

MeasureTime frameDescription
Tumor Motion Related to Breathing as Determined From MRI Images20 - 30 seconds1. 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

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Group 1
MRI with Breath Hold
10
Total10

Baseline characteristics

CharacteristicGroup 1
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

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

Time frame: 20 - 30 seconds

Population: Data were not analyzed due to study termination.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026