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

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02694029
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Active Breathing Coordinator (ABC); Device: VisionRT	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Sep 4, 2018
• Actual Study Completion Date: Sep 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ABC (Active Breathing Coordinator ), 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	Device: 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; Device: 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.; Other Names: AlignRT system
Active Comparator: VisionRT (VRT), 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	Device: 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; Device: 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.; Other Names: AlignRT system

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Asal Rahimi, MD, UT Southwestern Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 3, 2019

More Information

Publications

None provided.

• Responsible Party: Asal Rahimi, ASSOC PROFESSOR, Radiation Oncology - RO-Radiation Oncology, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02694029
• Other Study ID Numbers: STU 052015-047
• First Posted: Feb 29, 2016
• Last Update Posted: Aug 6, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Recruitment Details	Out of 11 participants consented, 1 participant withdrew before randomization

Arm/Group Title	Arm 1: ABC, Then VRT	Arm 2: VRT, Then ABC
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	5	5
First Intervention	5	5
Second Intervention	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm 1: ABC, Then VRT	Arm 2: VisionRT, Then ABC	Total
Arm/Group Description	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	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.	Total of all reporting groups
Overall Participants	5	5	10
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 80%	4 80%	8 80%
>=65 years	1 20%	1 20%	2 20%
Sex: Female, Male (Count of Participants)
Female	5 100%	5 100%	10 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	4 80%	4 80%	8 80%
Black or African American	1 20%	1 20%	2 20%
Region of Enrollment (participants) [Number]
United States	5 100%	5 100%	10 100%

Outcome Measures

1. Primary Outcome

Title	Residual Motion During Deep Inspiratory Breath-Hold (DIBH)
Description	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.
Time Frame	All patients received treatment for 2 hours for a minimum of 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation With ABC	Radiation VRT
Arm/Group Description	Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-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	VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-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
Measure Participants	10	10
Mean (Full Range) [mm]	0.27	0.27

2. Secondary Outcome

Title	Time of Simulation
Description	To compare time of simulation and daily treatment for DIBH with both ABC and Vision RT
Time Frame	All patients received treatment for 2 hours for a minimum of 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation With ABC	Radiation With VRT
Arm/Group Description	Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-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	VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-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
Measure Participants	10	10
Mean (Standard Deviation) [minutes]	40.0 (8)	29.8 (11.4)

3. Secondary Outcome

Title	Time of Treatment in Minutes
Description	To compare time of simulation and daily treatment for DIBH with both ABC and Vision RT
Time Frame	All patients received treatment for 2 hours for a minimum of 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation With ABC	Radiation With VisionRT
Arm/Group Description	Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-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	VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-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
Measure Participants	10	10
Mean (Standard Deviation) [minutes]	9.9 (3.7)	9.7 (3.8)

4. Secondary Outcome

Title	Reproducibility as Measure of Absolute Change of Breathing Chest Wall Excursion
Description	Reproducibility is defined as the repeatability of inter and intra-fraction DIBH levels. Reproducibility as measure of absolute change of breathing chest wall excursion
Time Frame	All patients received treatment for 2 hours for a minimum of 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation With ABC	Radiation With VisionRT
Arm/Group Description	Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-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	VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-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
Measure Participants	10	10
Mean (Full Range) [mm]	0.51	0.54

5. Secondary Outcome

Title	Radiation Dose to Heart
Description	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.
Time Frame	All patients received treatment for 2 hours for a minimum of 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation With ABC	Radiation With VRT
Arm/Group Description	Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-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	VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-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
Measure Participants	10	10
Mean (Standard Deviation) [GY]	1.6 (0.7)	1.6 (0.7)

6. Secondary Outcome

Title	Radiation Dose to Lung
Description	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.
Time Frame	All patients received treatment for 2 hours for a minimum of 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation With ABC	Radiation With VisionRT
Arm/Group Description	Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-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	VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-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
Measure Participants	10	10
Mean (Standard Deviation) [GY]	6.3 (1.4)	6.3 (1.4)

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	Adverse events were reviewed by treating physicians throughout the treatment duration through standard assessments.
Arm/Group Title	Radiation With ABC		Radiation With VisionRT
Arm/Group Description	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		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.
All Cause Mortality
	Radiation With ABC		Radiation With VisionRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Radiation With ABC		Radiation With VisionRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Radiation With ABC		Radiation With VisionRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.