Low-dose RaDiation therapy for patients with KNee osteoArthritis (LoRD-KNeA): a protocol for a sham-controlled randomised trial

Abstract

IntroductionLow-dose radiation therapy (LDRT) for osteoarthritis (OA) has been performed for several decades. However, supporting evidence from randomised studies using modern methodologies is lacking, and a recently published randomised study failed to show the significant benefit of LDRT. The presented trial aims to evaluate the efficacy and safety of LDRT for patients with knee OA.Methods and analysisThis prospective, multicentre, randomised trial will be conducted in the Republic of Korea. A total of 114 participants will be randomly assigned (1:1:1) to receive sham irradiation, 0.3 Gy/6 fractions of LDRT or 3 Gy/6 fractions of LDRT. Key inclusion criteria are primary knee OA with Kellgren-Lawrence grade 2–3 and visual analogue scale 50–90 when walking at the baseline. The primary endpoint is the rate of responders at 4 months after LDRT according to the OARSI-OMERACT criteria. Concomitant use of analgesics is prohibited until the primary efficacy evaluation is scheduled.Ethics and disseminationCurrently, approval from the Ministry of Food and Drug Safety of the Republic of Korea and the institutional review board of each participating hospital has been obtained. Patient enrolment began in October 2022 and is ongoing at three participating sites. The results will be disseminated to academic audiences and the public via publication in an international peer-reviewed journal and presentation at conferences. This trial will provide valuable information on the safety and efficacy of LDRT for patients with knee OA.Trial registration numberNCT05562271.

Evaluation of Efficacy and Safety Using Low Dose Radiation Therapy with Alzheimer’s Disease: A Protocol for Multicenter Phase II Clinical Trial

“…As for the twice weekly regimen rather than a daily RT, it was related to the LDRT as a treatment for osteoarthritis (OA). Several studies have demonstrated the efficacy of LDRT in modulating immune function, and it is used in European countries to relieve the symptoms of uncontrollable OA [26][27][28]. The most common regimen is to perform LDRT two to three times a week [28].…”

“…Several studies have demonstrated the efficacy of LDRT in modulating immune function, and it is used in European countries to relieve the symptoms of uncontrollable OA [26][27][28]. The most common regimen is to perform LDRT two to three times a week [28]. The interfraction interval is based on research by Moon et al [29].…”

CycleGAN-Driven MR-Based Pseudo-CT Synthesis for Knee Imaging Studies

“…positron emission tomography (PET) plays a crucial role in assessing metabolic activity in tissues, where accurate attenuation correction is imperative to derive precise and quantifiable metabolic information [7][8][9]. Furthermore, when it comes to therapy, radiation therapy planning requires the precise delivery of radiation to target tissue while minimizing exposure to surrounding healthy structures, where the level of accuracy in targeting is critical to the effectiveness and safety of the treatment [10,11]. Conventionally, CT scans are fundamental for both attenuation correction and radiation therapy planning, serving as the primary modality for generating patient-specific attenuation maps.…”