Trial Outcomes & Findings for Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer (NCT NCT02694029)
NCT ID: NCT02694029
Last Updated: 2021-08-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
All patients received treatment for 2 hours for a minimum of 6 weeks
Results posted on
2021-08-06
Participant Flow
Out of 11 participants consented, 1 participant withdrew before randomization
Participant milestones
| Measure |
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
|
Arm 2: 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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
First Intervention
|
5
|
5
|
|
Overall Study
Second Intervention
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: ABC, Then VRT
n=5 Participants
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
|
Arm 2: VisionRT, Then ABC
n=5 Participants
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
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: All patients received treatment for 2 hours for a minimum of 6 weeksResidual 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.
Outcome measures
| Measure |
Radiation With ABC
n=10 Participants
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
|
Radiation VRT
n=10 Participants
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
|
|---|---|---|
|
Residual Motion During Deep Inspiratory Breath-Hold (DIBH)
|
0.27 mm
Interval -3.0 to 3.1
|
0.27 mm
Interval -1.8 to 1.8
|
SECONDARY outcome
Timeframe: All patients received treatment for 2 hours for a minimum of 6 weeksTo compare time of simulation and daily treatment for DIBH with both ABC and Vision RT
Outcome measures
| Measure |
Radiation With ABC
n=10 Participants
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
|
Radiation VRT
n=10 Participants
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
|
|---|---|---|
|
Time of Simulation
|
40.0 minutes
Standard Deviation 8
|
29.8 minutes
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: All patients received treatment for 2 hours for a minimum of 6 weeksTo compare time of simulation and daily treatment for DIBH with both ABC and Vision RT
Outcome measures
| Measure |
Radiation With ABC
n=10 Participants
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
|
Radiation VRT
n=10 Participants
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
|
|---|---|---|
|
Time of Treatment in Minutes
|
9.9 minutes
Standard Deviation 3.7
|
9.7 minutes
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: All patients received treatment for 2 hours for a minimum of 6 weeksReproducibility is defined as the repeatability of inter and intra-fraction DIBH levels. Reproducibility as measure of absolute change of breathing chest wall excursion
Outcome measures
| Measure |
Radiation With ABC
n=10 Participants
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
|
Radiation VRT
n=10 Participants
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
|
|---|---|---|
|
Reproducibility as Measure of Absolute Change of Breathing Chest Wall Excursion
|
0.51 mm
Interval -11.1 to 8.5
|
0.54 mm
Interval -5.9 to 8.8
|
SECONDARY outcome
Timeframe: All patients received treatment for 2 hours for a minimum of 6 weeksThe 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.
Outcome measures
| Measure |
Radiation With ABC
n=10 Participants
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
|
Radiation VRT
n=10 Participants
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
|
|---|---|---|
|
Radiation Dose to Heart
|
1.6 GY
Standard Deviation 0.7
|
1.6 GY
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: All patients received treatment for 2 hours for a minimum of 6 weeksThe 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.
Outcome measures
| Measure |
Radiation With ABC
n=10 Participants
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
|
Radiation VRT
n=10 Participants
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
|
|---|---|---|
|
Radiation Dose to Lung
|
6.3 GY
Standard Deviation 1.4
|
6.3 GY
Standard Deviation 1.4
|
Adverse Events
Radiation With ABC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Radiation With VisionRT
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place