A total inverse planning paradigm: prospective clinical trial evaluating the performance of a novel MR-based 3D-printed head immobilization device

•Generation of a 3D-printed mask (3Dp-mask) from MR imaging to manufacture a reproducible positioning and immobilization.•Prospective trial comparing the performance of the 3Dp-mask and standard thermoplastic mask.•3D-p mask yielded comparable inter-fraction motion, while better patient-reported exp...

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Published in:	Clinical and translational radiation oncology 2023-09, Vol.42, p.100663-100663, Article 100663
Main Authors:	Anna Jablonska, Paola, Parent, Amy, La Macchia, Nancy, Chan, Harley H.L., Filleti, Matthew, Ramotar, Matthew, Cho, Young-Bin, Braganza, Maria, Badzynski, Adam, Laperriere, Normand, Conrad, Tatiana, Tsang, Derek S., Shultz, David, Santiago, Anna, Irish, Jonathan C., Millar, Barbara-Ann, Tadic, Tony, Berlin, Alejandro
Format:	Article
Language:	eng
Subjects:	3D printing Immobilization device Mask MR-guidance Original Radiotherapy
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Summary:	•Generation of a 3D-printed mask (3Dp-mask) from MR imaging to manufacture a reproducible positioning and immobilization.•Prospective trial comparing the performance of the 3Dp-mask and standard thermoplastic mask.•3D-p mask yielded comparable inter-fraction motion, while better patient-reported experience.•The proposed approach unlocks a ‘total inverse planning’ paradigm that may improve CNS radiotherapy workflows and value of care. Brain radiotherapy (cnsRT) requires reproducible positioning and immobilization, attained through redundant dedicated imaging studies and a bespoke moulding session to create a thermoplastic mask (T-mask). Innovative approaches may improve the value of care. We prospectively deployed and assessed the performance of a patient-specific 3D-printed mask (3Dp-mask), generated solely from MR imaging, to replicate a reproducible positioning and tolerable immobilization for patients undergoing cnsRT. Patients undergoing LINAC-based cnsRT (primary tumors or resected metastases) were enrolled into two arms: control (T-mask) and investigational (3Dp-mask). For the latter, an in-house designed 3Dp-mask was generated from MR images to recreate the head positioning during MR acquisition and allow coupling with the LINAC tabletop. Differences in inter-fraction motion were compared between both arms. Tolerability was assessed using patient-reported questionnaires at various time points. Between January 2020 - July 2022, forty patients were enrolled (20 per arm). All participants completed the prescribed cnsRT and study evaluations. Average 3Dp-mask design and printing completion time was 36h:50min (range 12h:56min - 42h:01min). Inter-fraction motion analyses showed three-axis displacements comparable to the acceptable tolerance for the current standard-of-care. No differences in patient-reported tolerability were seen at baseline. During the last week of cnsRT, 3Dp-mask resulted in significantly lower facial and cervical discomfort and patients subjectively reported less pressure and confinement sensation when compared to the T-mask. No adverse events were observed. The proposed total inverse planning paradigm using a 3D-printed immobilization device is feasible and renders comparable inter-fraction performance while offering a better patient experience, potentially improving cnsRT workflows and its cost-effectiveness.
ISSN:	2405-6308 2405-6308