Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Respiratory Aspiration

Breast Neoplasms

Breast Diseases

Skin Diseases

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-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

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

Active Breathing Coordinator (ABC)

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.

VisionRT

Asal Rahimi, MD

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.

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

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.

To compare time of simulation and daily treatment for DIBH with both ABC and Vision RT

Reproducibility is defined as the repeatability of inter and intra-fraction DIBH levels. Reproducibility as measure of absolute change of breathing chest wall excursion

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.

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.

University of Texas Southwestern Medical Center

ASSOC PROFESSOR, Radiation Oncology - RO-Radiation Oncology

Adverse events were reviewed by treating physicians throughout the treatment duration through standard assessments.

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

Radiation With 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.

Radiation With VisionRT

Arm 1: ABC, Then VRT

Arm 2: VisionRT, Then ABC

Total

Age, Categorical

Sex: Female, Male

White

Black or African American

Race/Ethnicity, Customized

United States

Region of Enrollment

Breast cancer patients undergoing radiation.

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

Radiation VRT

Residual Motion During Deep Inspiratory Breath-Hold (DIBH)

Radiation With VRT

Time of Simulation

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

Time of Treatment in Minutes

Reproducibility as Measure of Absolute Change of Breathing Chest Wall Excursion

Radiation Dose to Heart

Radiation Dose to Lung

Arm 2: VRT, Then ABC

Overall Study

Respiration Disorders

Respiratory Tract Diseases

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.

Radiation Therapy

Pramila Rani Anne, MD

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.

Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer

A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients

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.

Number of participants that experienced grade three toxicity or higher as a result of treatment.

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.

To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.

Sidney Kimmel Cancer Center at Thomas Jefferson University

Serious Adverse Events and Other Adverse Events were not collected/assessed.

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.

Active Breathing Coordinator

Age, Continuous

Rani Anne, MD

Free breathing (heart)

ABC (heart)

Free breathing (lung)

ABC (lung)

Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues

5% reduction (heart)

20% reduction (heart)

5% reduction (lung)

20% reduction (lung)

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.

Proportion of Patients With Reduction in Radiation

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.

Radiation Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer	NCT02694029	Breast Cancer	Active Breathin... VisionRT	18 Years - 99 Years	University of Texas Southwestern Medical Center
Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer	NCT02694029	Breast Cancer	Active Breathin... VisionRT	18 Years - 99 Years	University of Texas Southwestern Medical Center
Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer	NCT02694029	Breast Cancer	Active Breathin... VisionRT	18 Years - 99 Years	University of Texas Southwestern Medical Center
Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer	NCT00328783	Breast Cancer	Active Breathin... Radiation Thera...	18 Years -	Thomas Jefferson University

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