Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2002-31 | Other Identifier | CCRRC | |
| JT 1005 | Other Identifier | JeffTrial Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.
The Active Breathing Coordinator (ABC) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. While ABC is FDA approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. There is some data using ABC for intrathoracic malignancies, which shows that it is feasible and safe to use. ABC can be used to optimize the distance between chest wall, heart and liver. This allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Breathing Coordinator | Experimental | Patients breathe through the ABC device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Breathing Coordinator (ABC) | Device | The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. |
| Measure | Description | Time Frame |
|---|---|---|
| Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues | To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing. The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose. | At time of radiation |
| Proportion of Patients With Reduction in Radiation | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity Evaluation | Number of participants that experienced grade three toxicity or higher as a result of treatment. | 30 days post-treatment |
| Change in Organs at Risk (OAR) Dosimetric Paramaters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pramila Rani Anne, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19017 | United States |
Not provided
| Label | URL |
|---|---|
| Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center | View source |
| Thomas Jefferson University Hospitals | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Breathing Coordinator | Patients breathe through the ABC device Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Radiation Therapy | Radiation |
|
To evaluate the magnitude of change in Mean Heart Dose (MHD) and Left lung dose when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.
| 30 days post-treatment |
| Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device. | To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device. | 30 days post-treatment |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Breathing Coordinator | Patients breathe through the ABC device Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues | To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing. The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose. | Posted | Mean | 95% Confidence Interval | Gy | At time of radiation |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Proportion of Patients With Reduction in Radiation | Posted | Number | 95% Confidence Interval | proportion of patients | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Toxicity Evaluation | Number of participants that experienced grade three toxicity or higher as a result of treatment. | Posted | Count of Participants | Participants | 30 days post-treatment |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Organs at Risk (OAR) Dosimetric Paramaters | To evaluate the magnitude of change in Mean Heart Dose (MHD) and Left lung dose when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing. | Posted | Mean | 95% Confidence Interval | Gy | 30 days post-treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device. | To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device. | Posted | Count of Participants | Participants | 30 days post-treatment |
|
|
Not provided
Serious Adverse Events and Other Adverse Events were not collected/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Breathing Coordinator | Patients breathe through the ABC device Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rani Anne, MD | Thomas Jefferson University | 215-955-6045 | Rani.Anne@jeffersonhospital.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| ABC (lung) |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| 5% reduction (heart) |
| |||||
| 20% reduction (heart) |
| |||||
| 5% reduction (lung) |
| |||||
| 20% reduction (lung) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|