Multidrug chemotherapy, whole-brain radiation and cytarabine therapy for primary central nervous system lymphoma in elderly patients with dose modification based on geriatric assessment: study protocol for a phase II, multicentre, non-randomised study.

INTRODUCTION: Multidrug chemoimmunotherapy with rituximab, high-dose methotrexate, procarbazine and vincristine (R-MPV) is a standard therapy for younger patients with primary central nervous system lymphoma (PCNSL); however, prospective data regarding its use in elderly patients are lacking. This multi-institutional, non-randomised, phase II trial will assess the efficacy and safety of R-MPV and high-dose cytarabine (HD-AraC) for geriatric patients with newly diagnosed PCNSL. METHODS AND ANALYSIS: Forty-five elderly patients will be included. If R-MPV does not achieve complete response, the patients will undergo reduced-dose, whole-brain radiotherapy comprising 23.4 Gy/13 fractions, followed by local boost radiotherapy comprising 21.6 Gy/12 fractions. After achieving complete response using R-MPV with or without radiotherapy, the patients will undergo two courses of HD-AraC. All patients will undergo baseline geriatric 8 (G8) assessment before HD-AraC and after three, five and seven R-MPV courses. Patients with screening scores of ≥14 points that decrease to <14 points during subsequent treatment, or those with screening scores <14 points that decrease from the baseline during subsequent treatment are considered unfit for R-MPV/HD-AraC. The primary endpoint is overall survival, and the secondary endpoints are progression-free survival, treatment failure-free survival and frequency of adverse events. The results will guide a later phase III trial and provide information about the utility of a geriatric assessment for defining chemotherapy ineligibility. ETHICS AND DISSEMINATION: This study complies with the latest Declaration of Helsinki. Written informed consent will be obtained. All participants can quit the study without penalty or impact on treatment. The protocol for the study, statistical analysis plan and informed consent form have been approved by the Certified Review Board at Hiroshima University (CRB6180006) (approval number: CRB2018-0011). The study is ongoing within nine tertiary and two secondary hospitals in Japan. The findings of this trial will be disseminated through national and international presentations and peer-reviewed publications. TRIAL REGISTRATION: jRCTs061180093.

Kinematic MRI of the normal ankle ligaments using a specially designed passive positioning device.

BACKGROUND: Knowledge of the normal MRI appearances of the ankle ligaments and tendons is particularly important in the diagnosis of ankle sprains. In most clinical practices, the ankle is imaged in a neutral position with standard imaging planes and sequences. The purpose of our study was to investigate whether passive positioning influences the MRI appearances of the ligaments of the ankle. METHODS: The axial and coronal T1-weighted MR images obtained from 10 subjects were reviewed by two musculoskeletal radiologists. The following imaging planes were used: dorsiflexion with inversion, dorsiflexion with neutral, dorsiflexion with eversion, neutral with inversion, neutral, neutral with eversion, plantarflexion with inversion, plantarflexion with neutral, and plantarflexion with eversion. A subjective rating system was used to determine the optimal imaging plane and position for individual ligaments in each volunteer. Each ligament was rated on a scale (of 1 to 6). RESULTS: There were significant differences in the appearances of the anterior talofibular (p = 0.0002), calcaneofibular (p < 0.0001), and posterior talofibular (p < 0.0001) ligaments between the optimal and least optimal ankle positions in the axial plane, and in those of the (plantar calcaneonavicular) spring (p < 0.0001), tibiocalcaneal (p < 0.0001), posterior tibiotalar (p = 0.0087) and posterior talofibular (p = 0.0213) ligaments in the coronal plane. CONCLUSIONS: Kinematic MRI of the ankle is feasible and appears to improve visualization of ankle ligaments compared to MRI.