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Completed

NCT Number: NCT02694029

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

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).

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Other names: AlignRT system

Primary outcomes

  1. Residual Motion During Deep Inspiratory Breath-Hold (DIBH)

    Time frame: 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 outcomes

  1. Time of Simulation

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study 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

Acronym: VisionRT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 29, 2016
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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