RESUMO
PURPOSE: The O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) PET in Glioblastoma (FIG) trial is an Australian prospective, multi-centre study evaluating FET PET for glioblastoma patient management. FET PET imaging timepoints are pre-chemoradiotherapy (FET1), 1-month post-chemoradiotherapy (FET2), and at suspected progression (FET3). Before participant recruitment, site nuclear medicine physicians (NMPs) underwent credentialing of FET PET delineation and image interpretation. METHODS: Sites were required to complete contouring and dynamic analysis by ≥ 2 NMPs on benchmarking cases (n = 6) assessing biological tumour volume (BTV) delineation (3 × FET1) and image interpretation (3 × FET3). Data was reviewed by experts and violations noted. BTV definition includes tumour-to-background ratio (TBR) threshold of 1.6 with crescent-shaped background contour in the contralateral normal brain. Recurrence/pseudoprogression interpretation (FET3) required assessment of maximum TBR (TBRmax), dynamic analysis (time activity curve [TAC] type, time to peak), and qualitative assessment. Intraclass correlation coefficient (ICC) assessed volume agreement, coefficient of variation (CoV) compared maximum/mean TBR (TBRmax/TBRmean) across cases, and pairwise analysis assessed spatial (Dice similarity coefficient [DSC]) and boundary agreement (Hausdorff distance [HD], mean absolute surface distance [MASD]). RESULTS: Data was accrued from 21 NMPs (10 centres, n ≥ 2 each) and 20 underwent review. The initial pass rate was 93/119 (78.2%) and 27/30 requested resubmissions were completed. Violations were found in 25/72 (34.7%; 13/12 minor/major) of FET1 and 22/74 (29.7%; 14/8 minor/major) of FET3 reports. The primary reasons for resubmission were as follows: BTV over-contour (15/30, 50.0%), background placement (8/30, 26.7%), TAC classification (9/30, 30.0%), and image interpretation (7/30, 23.3%). CoV median and range for BTV, TBRmax, and TBRmean were 21.53% (12.00-30.10%), 5.89% (5.01-6.68%), and 5.01% (3.37-6.34%), respectively. BTV agreement was moderate to excellent (ICC = 0.82; 95% CI, 0.63-0.97) with good spatial (DSC = 0.84 ± 0.09) and boundary (HD = 15.78 ± 8.30 mm; MASD = 1.47 ± 1.36 mm) agreement. CONCLUSION: The FIG study credentialing program has increased expertise across study sites. TBRmax and TBRmean were robust, with considerable variability in BTV delineation and image interpretation observed.
Assuntos
Neoplasias Encefálicas , Ficus , Glioblastoma , Medicina Nuclear , Humanos , Glioblastoma/diagnóstico por imagem , Glioblastoma/patologia , Neoplasias Encefálicas/diagnóstico por imagem , Neoplasias Encefálicas/patologia , Estudos Prospectivos , Austrália , Tomografia por Emissão de Pósitrons/métodos , Tirosina , Imageamento por Ressonância MagnéticaRESUMO
BACKGROUND: There is currently a lack of evidence to identify the optimal patellar implant design in total knee arthroplasty (TKA). The aim of this study was to assess clinical, intraoperative, radiographic, and scintigraphic differences between inlay (IN), onlay round (OR), and onlay oval (OO) patellar implants. METHODS: A parallel-group, double-blinded, randomized trial compared IN, OR, and OO patellar implants using the same posterior-stabilized TKA prosthesis for each. Patient outcomes were prospectively followed for a minimum of 2 years, with survivorship outcomes followed for a mean of 5 years. The primary outcome was the between-group differences in the mean Kujala score change from preoperatively to 2 years postoperatively. The secondary outcomes included differences in other knee-specific and general health outcomes, intraoperative characteristics, radiographic parameters, patellar vascularity, and implant survivorship. RESULTS: A total of 121 participants (40 in the IN group, 41 in OR group, 40 in the OO group) were allocated to 1 of 3 implant designs. At 2 years postoperatively, there were no significant differences in Kujala score changes between groups (p = 0.7; Kruskal-Wallis test). Compared with the IN group, the OR group showed greater improvements in Knee injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living and in KOOS Quality of Life compared with the OO group. However, the OO design exhibited better bone coverage and lower lateral facetectomy rates compared with the IN and OR designs. The IN group had more lateral contact compared with the OO group (p = 0.02; Fisher exact test), but the overall value for lateral contact was not significant (p = 0.09; chi-square test). There were no differences in postoperative scintigraphic vascularity (p = 0.8; chi-square test). There was 1 revision for infection at 3 years postoperatively in the OO group, and no revision in the other groups. CONCLUSIONS: Patellar design did not influence patellofemoral outcomes or survivorship. However, OR implants showed improvements in some secondary patient-reported outcome measures, and OO implants exhibited superior bone coverage and improvements in several intraoperative, radiographic, and scintigraphic outcomes. These findings, combined with superior long-term implant survivorship from previous studies, add support for the use of onlay designs in TKA. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.