1. A Novel Device for Deep-Inspiration Breath Hold (DIBH): Results from a Single-Institution Phase 2 Clinical Trial for Patients with Left-Sided Breast Cancer
- Author
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Diego Jurado-Bruggeman, Albert Onsès-Segarra, Maria Buxó, Rafael Fuentes-Raspall, Carles Muñoz-Montplet, Ingrid Romera-Martínez, and Joan C. Vilanova
- Subjects
Population ,Phases of clinical research ,Pilot Projects ,Anterior Descending Coronary Artery ,Left sided ,030218 nuclear medicine & medical imaging ,Breath Holding ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Unilateral Breast Neoplasms ,Humans ,Medicine ,Radiology, Nuclear Medicine and imaging ,education ,Deep inspiration breath-hold ,Reproducibility ,education.field_of_study ,business.industry ,Repeatability ,Middle Aged ,medicine.disease ,Inhalation ,Oncology ,030220 oncology & carcinogenesis ,Female ,business ,Nuclear medicine - Abstract
Purpose To validate a novel device developed at our institution for deep inspiration breath hold (DIBH) within a phase 2 clinical trial for left-sided breast cancer and to evaluate the dosimetric benefits of its use. Methods and Materials The device uses an external mechanical reference for guiding the patient to the desired breath level and gives acoustic and visual feedback to the patient and the radiation therapists, respectively. A phase 2 clinical trial was performed for its validation. The thoracic amplitude was used as a surrogate of the inspiration level. The stability, repeatability, reproducibility, and reliability of DIBH using the device were analyzed. The dosimetric parameters of the heart, the left anterior descending coronary artery, the ipsilateral lung, the contralateral breast, and the target coverage using free breathing and DIBH were compared. Results Thirty-eight patients were included in the analysis. The maximum population value of stability and repeatability were 1.7 mm and 3.3 mm, respectively. The reproducibility mean value was 1.7 mm, and population systematic and random errors were 0.3 mm and 0.9 mm, respectively. The reliability was 98.9%. Statistically significant dose reductions were found for the heart, the left anterior descending coronary artery, and the ipsilateral lung dosimetric parameters in DIBH, without losing dose coverage to the planning target volumes. Conclusions The validation of the device within the phase 2 clinical trial demonstrates that it offers reliable, stable, repeatable, and reproducible breast cancer treatments in DIBH with its dosimetric benefits.
- Published
- 2020