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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC (Active Breathing Coordinator ), Then VRT | Active Comparator | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Breathing Coordinator (ABC) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | All patients received treatment for 2 hours for a minimum of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Simulation | To compare time of simulation and daily treatment for DIBH with both ABC and Vision RT | All patients received treatment for 2 hours for a minimum of 6 weeks |
| Time of Treatment in Minutes |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asal Rahimi, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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Out of 11 participants consented, 1 participant withdrew before randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Breast cancer patients undergoing radiation.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | mm | All patients received treatment for 2 hours for a minimum of 6 weeks |
|
30 days
Adverse events were reviewed by treating physicians throughout the treatment duration through standard assessments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiation With 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 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Asal Rahimi, MD | UT Southwestern Medical Center | 214/645-8556 | Asal.Rahimi@UTSouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2019 | May 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| VisionRT | Device | 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. |
|
|
To compare time of simulation and daily treatment for DIBH with both ABC and Vision RT
| All patients received treatment for 2 hours for a minimum of 6 weeks |
| Reproducibility as Measure of Absolute Change of Breathing Chest Wall Excursion | Reproducibility is defined as the repeatability of inter and intra-fraction DIBH levels. Reproducibility as measure of absolute change of breathing chest wall excursion | All patients received treatment for 2 hours for a minimum of 6 weeks |
| Radiation Dose to Heart | 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. | All patients received treatment for 2 hours for a minimum of 6 weeks |
| Radiation Dose to Lung | 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. | All patients received treatment for 2 hours for a minimum of 6 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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
|
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| Secondary | Time of Simulation | To compare time of simulation and daily treatment for DIBH with both ABC and Vision RT | Posted | Mean | Standard Deviation | minutes | All patients received treatment for 2 hours for a minimum of 6 weeks |
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| Secondary | Time of Treatment in Minutes | To compare time of simulation and daily treatment for DIBH with both ABC and Vision RT | Posted | Mean | Standard Deviation | minutes | All patients received treatment for 2 hours for a minimum of 6 weeks |
|
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| Secondary | Reproducibility as Measure of Absolute Change of Breathing Chest Wall Excursion | Reproducibility is defined as the repeatability of inter and intra-fraction DIBH levels. Reproducibility as measure of absolute change of breathing chest wall excursion | Posted | Mean | Full Range | mm | All patients received treatment for 2 hours for a minimum of 6 weeks |
|
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| Secondary | Radiation Dose to Heart | 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. | Posted | Mean | Standard Deviation | GY | All patients received treatment for 2 hours for a minimum of 6 weeks |
|
|
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| Secondary | Radiation Dose to Lung | 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. | Posted | Mean | Standard Deviation | GY | All patients received treatment for 2 hours for a minimum of 6 weeks |
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| 0 |
| 10 |
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| 10 |
| 0 |
| 10 |
| EG001 | Radiation With 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: 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D017437 |
| Skin and Connective Tissue Diseases |