Radiation Enhancement Using Focussed Ultrasound-Stimulated Microbubbles for Head and Neck Cancer: A Phase 1 Clinical Trial
Radiotherapy and oncology journal of the European Society for Therapeutic Radiology and Oncology(2024)
摘要
Background and purposePreclinical research demonstrated that the exposure of microbubbles (intravascular gas microspheres) to focussed ultrasound within the targeted tumour upregulates pro-apoptotic pathways and enhances radiation-induced tumour cell death. This study aimed to assess the safety and efficacy of magnetic resonance (MR)-guided focussed ultrasound-stimulated microbubbles (MRgFUS-MB) for head and neck cancers (HN).Materials and methodsThis prospective phase 1 clinical trial included patients with newly diagnosed or recurrent HN cancer (except nasopharynx malignancies) for whom locoregional radiotherapy with radical- or palliative-intent as deemed appropriate. Patients with contraindications for microbubble administration or contrast-enhanced MR were excluded. MR-coupled focussed ultrasound sonicated intravenously administered microbubbles within the MR-guided target volume. Patients receiving 5–10 and 33–35 radiation fractions were planned for 2 and 3 MRgFUS-MB treatments, respectively. Primary endpoint was toxicity per CTCAEv5.0. Secondary endpoint was tumour response at 3 months per RECIST 1.1 criteria.ResultsTwelve patients were enrolled between Jun/2020 and Nov/2023, but 1 withdrew consent. Eleven patients were included in safety analysis. Median follow-up was 7 months (range, 0.3–38). Most patients had oropharyngeal cancer (55 %) and received 20–30 Gy/5–10 fractions (63 %). No systemic toxicity or MRgFUS-MB-related adverse events occurred. The most severe acute adverse events were radiation-related grade 3 toxicities in 6 patients (55 %; dermatitis in 3, mucositis in 1, dysphagia in 6). No radiation necrosis or grade 4/5 toxicities were reported. 8 patients were included in the 3-month tumour response assessment: 4 had partial response (50 %), 3 had complete response (37.5 %), and 1 had progressive disease (12.5 %).ConclusionsMRgFUS-MB treatment was safe and associated with high rates of tumour response at 3 months.
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关键词
Microbubbles,Radiotherapy,Radiation-sensitizing agents,Magnetic resonance imaging,Focussed ultrasound,Ultrasonography,Head and neck neoplasms
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