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

Intra-patient Comparison of Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Left-chest Wall Irradiation, a Pilot Study for Breast Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02694029

Acronym

VisionRT

Enrollment

Registered

2016-02-29

Start date

2016-02-29

Completion date

2018-09-04

Last updated

2021-08-06

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

Conditions

Breast Cancer

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.

Interventions

DEVICEActive Breathing Coordinator (ABC)

The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH

DEVICEVisionRT

A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 99 Years

Healthy volunteers

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)

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Participant flow

Recruitment details

Out of 11 participants consented, 1 participant withdrew before randomization

Participants by arm

Arm	Count
Arm 1: ABC, Then VRT 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 Active Breathing Coordinator (ABC): The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH	5
Arm 2: VisionRT, Then 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 VisionRT: A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH.	5
Total	10

Baseline characteristics

Characteristic	Arm 2: VisionRT, Then ABC	Total	Arm 1: ABC, Then VRT
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	2 Participants	1 Participants
Age, Categorical Between 18 and 65 years	4 Participants	8 Participants	4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants	2 Participants	1 Participants
Race/Ethnicity, Customized White	4 Participants	8 Participants	4 Participants
Region of Enrollment United States	5 participants	10 participants	5 participants
Sex: Female, Male Female	5 Participants	10 Participants	5 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 10
other Total, other adverse events	0 / 10	0 / 10
serious Total, serious adverse events	0 / 10	0 / 10

Outcome results

Primary

Residual Motion During Deep Inspiratory Breath-Hold (DIBH)

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.