FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach.

BACKGROUND: FLASH therapy is a treatment technique in which radiation is delivered at ultra-high dose rates (≥ 40 Gy/s). The first-in-human FAST-01 clinical trial demonstrated the clinical feasibility of proton FLASH in the treatment of extremity bone metastases. The objectives of this investigation are to assess the toxicities of treatment and pain relief in study participants with painful thoracic bone metastases treated with FLASH radiotherapy, as well as workflow metrics in a clinical setting. METHODS: This single-arm clinical trial is being conducted under an FDA investigational device exemption (IDE) approved for 10 patients with 1-3 painful bone metastases in the thorax, excluding bone metastases in the spine. Treatment will be 8 Gy in a single fraction administered at ≥ 40 Gy/s on a FLASH-enabled proton therapy system delivering a single transmission proton beam. Primary study endpoints are efficacy (pain relief) and safety. Patient questionnaires evaluating pain flare at the treatment site will be completed for 10 consecutive days post-RT. Pain response and adverse events (AEs) will be evaluated on the day of treatment and on day 7, day 15, months 1, 2, 3, 6, 9, and 12, and every 6 months thereafter. The outcomes for clinical workflow feasibility are the occurrence of any device issues as well as time on the treatment table. DISCUSSION: This prospective clinical trial will provide clinical data for evaluating the efficacy and safety of proton FLASH for palliation of bony metastases in the thorax. Positive findings will support the further exploration of FLASH radiation for other clinical indications including patient populations treated with curative intent. REGISTRATION: ClinicalTrials.gov NCT05524064.

Clinical characterization of a proton beam continuous uniform scanning system with dose layer stacking.

A proton beam delivery system on a gantry with continuous uniform scanning and dose layer stacking at the Midwest Proton Radiotherapy Institute has been commissioned and accepted for clinical use. This paper was motivated by a lack of guidance on the testing and characterization for clinical uniform scanning systems. As such, it describes how these tasks were performed with a uniform scanning beam delivery system. This paper reports the methods used and important dosimetric characteristics of radiation fields produced by the system. The commissioning data include the transverse and longitudinal dose distributions, penumbra, and absolute dose values. Using a 208 MeV cyclotron's proton beam, the system provides field sizes up to 20 and 30 cm in diameter for proton ranges in water up to 27 and 20 cm, respectively. The dose layer stacking method allows for the flexible construction of spread-out Bragg peaks with uniform modulation of up to 15 cm in water, at typical dose rates of 1-3 Gy/min. For measuring relative dose distributions, multielement ion chamber arrays, small-volume ion chambers, and radiographic films were employed. Measurements during the clinical commissioning of the system have shown that the lateral and longitudinal dose uniformity of 2.5% or better can be achieved for all clinically important field sizes and ranges. The measured transverse penumbra widths offer a slight improvement in comparison to those achieved with a double scattering beam spreading technique at the facility. Absolute dose measurements were done using calibrated ion chambers, thermoluminescent and alanine detectors. Dose intercomparisons conducted using various types of detectors traceable to a national standards laboratory indicate that the measured dosimetry data agree with each other within 5%.

Experiences with an application of industrial robotics for accurate patient positioning in proton radiotherapy.

BACKGROUND: Protons beams deliver targeted radiation doses with greater precision than is possible with electrons or megavoltage X-ray photons, but to retain this advantage, patient positioning systems at proton clinics must meet tighter accuracy requirements. For this and other reasons, robots were incorporated into the treatment room systems at MPRI. METHODS: The Midwest Proton Radiotherapy Institute (MPRI) is the first radiotherapy facility in the United States to use commercial robots with six degrees of freedom for patient positioning, rather than a traditional bed with four degrees of freedom. RESULTS: This paper outlines the ways in which robots are used at MPRI and attempts to distil insights from the experience of treating over 200 radiotherapy patients with a robotic system from February 2004 to late 2006. CONCLUSIONS: The system has performed well, and with great reliability, but there is room for future improvement, especially in ease of use and in reducing the time to get patients into position.