Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Active Breathing Coordinator (ABC); Device: VisionRT

• Registration Number: NCT02694029
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

Female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of Active Breathing Coordinator (ABC)-assisted and VisionRT-assisted Deep Inspiration Breath-Hold (DIBH).

Detailed Description

Female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of ABC-assisted and VisionRT-assisted DIBH. Residual motion during breath-hold will be quantitatively assessed using MV fluoroscopy from the treatment beam itself (i.e., no additional radiation dose). The dosimetric impact of residual motion on organs at risk (heart and lung) will be assessed by applying rigid and/or deformable displacements to the planning CT images, computing the 3D dose map and comparing with the original planned dose map.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-02-29
• Primary Completion: 2018-09-04
• Study Completion: 2018-09-04
• Results First Submitted: 2021-06-08
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Results First Posted: 2021-08-06
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

Inclusion Criteria

• Women with diagnosis of breast malignancy
• Women whom requires left chest wall post-mastectomy radiation with or without bolus
• Age ≥ 18 years.
• Performance status ECOG </=3
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Ability to understand and the willingness to sign a written informed consent.
• Patient must be able to maintain a 30 second breath hold.
• Conventional chest wall radiation delivery dose of 50.4 Gy/ 28 fractions with or without a boost (boost will not be evaluated for endpoints)

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Exclusion Criteria

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ABC (Active Breathing Coordinator ), Then VRT	Active Breathing Coordinator (ABC)	Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH
ABC (Active Breathing Coordinator ), Then VRT	VisionRT	Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH
VisionRT (VRT), Then ABC	VisionRT	VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH
VisionRT (VRT), Then ABC	Active Breathing Coordinator (ABC)	VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH

Primary Outcome Measures

Name	Time	Method
Residual Motion During Deep Inspiratory Breath-Hold (DIBH)	All patients received treatment for 2 hours for a minimum of 6 weeks	Residual motion is measured as range of breast/chest wall motion during the ABC or VisionRT assisted DIBH beam delivery. The range of motion will be measured in a unit of millimeter.

Secondary Outcome Measures

Name	Time	Method
Time of Simulation	All patients received treatment for 2 hours for a minimum of 6 weeks	To compare time of simulation and daily treatment for DIBH with both ABC and Vision RT
Time of Treatment in Minutes	All patients received treatment for 2 hours for a minimum of 6 weeks	To compare time of simulation and daily treatment for DIBH with both ABC and Vision RT
Reproducibility as Measure of Absolute Change of Breathing Chest Wall Excursion	All patients received treatment for 2 hours for a minimum of 6 weeks	Reproducibility is defined as the repeatability of inter and intra-fraction DIBH levels. Reproducibility as measure of absolute change of breathing chest wall excursion
Radiation Dose to Heart	All patients received treatment for 2 hours for a minimum of 6 weeks	The dosimetric impact of residual motion on heart will be assessed by measuring the radiation dose to heart. We will measure radiation dose by applying rigid displacement to the planing CT and comparing with the original planned dose map.
Radiation Dose to Lung	All patients received treatment for 2 hours for a minimum of 6 weeks	The dosimetric impact of residual motion on lung will be assessed by measuring the radiation dose to lung. We will measure radiation dose by applying rigid displacement to the planing CT and comparing with the original planned dose map.

Trial Locations

Locations (1)

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States