Guerbet highlights marketing approval of Elucirem in EU

AuntMinnieEurope.com staff writers

Dec 12, 2023

Guerbet is highlighting that the European Commission has approved the marketing of Elucirem (gadopiclenol).

Elucirem is a macrocyclic gadolinium-based contrast agent (GBCA) for use in contrast-enhanced MRI. The company said it has high relaxivity and is indicated for adults and children aged 2 and older to improve detection and visualization of pathologies with disruption of the blood-brain barrier. This also includes abnormal vascularity of the brain, spine, and associated tissues of the central nervous system, as well as the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.

Guerbet said that the European Commission is the second regulatory organization to approve Elucirem, with further evaluation continuing in other countries.

Gadopiclenol is sold under the trade names Vueway and Elucirem by Bracco and Guerbet respectively.

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Preablation, postablation, and recurrence multiparametric MRI scans depict a 63-year-old man treated with transperineal focal laser ablation (TPLA) for localized prostate cancer. Clinical parameters included an initial prostate-specific antigen (PSA) level of 7.2 ng/mL, a Prostate Imaging Reporting and Data System (PI-RADS) grade 4 lesion (red circles) in the right apical peripheral zone, and a maximum tumor length of 5 mm. MRI-guided targeted biopsy confirmed a Gleason score 3+4 prostate cancer tumor. (A) Pre-ablation axial T2-weighted MRI scan and apparent diffusion coefficient (ADC) image shows the apical PI-RADS 4 lesion (circles). (B) Six-month post-ablation axial T2-weighted MRI scan and ADC image show cystic necrosis (arrows). There was no evidence of recurrence; the PSA level was 1.5 ng/mL. (C) One-year after ablation, the patient’s PSA level had increased to 4.3 ng/mL. Axial T2-weighted MRI scan and the ADC image shows a recurrent lesion (blue circles) in the right apical peripheral zone adjacent to the ablation scar. Targeted biopsy confirmed Gleason score 3+4 prostate cancer, which was classified as in-field recurrence of clinically significant prostate cancer and subsequently re-treated with TPLA. In summary, serial multiplanar MRI demonstrates treatment response after TPLA with post-ablation necrosis, followed by MRI-detected IFR confirmed with biopsy at 12-month follow-up. Multiparametric MRI was performed with a 3.0-T MRI scanner (Skyra; Siemens Healthineers) using T2-weighted, diffusion-weighted, and ADC sequences, with gadobenate dimeglumine contrast material administration (Bracco Diagnostics).

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Preablation, postablation, and recurrence multiparametric MRI scans depict a 63-year-old man treated with transperineal focal laser ablation (TPLA) for localized prostate cancer. Clinical parameters included an initial prostate-specific antigen (PSA) level of 7.2 ng/mL, a Prostate Imaging Reporting and Data System (PI-RADS) grade 4 lesion (red circles) in the right apical peripheral zone, and a maximum tumor length of 5 mm. MRI-guided targeted biopsy confirmed a Gleason score 3+4 prostate cancer tumor. (A) Pre-ablation axial T2-weighted MRI scan and apparent diffusion coefficient (ADC) image shows the apical PI-RADS 4 lesion (circles). (B) Six-month post-ablation axial T2-weighted MRI scan and ADC image show cystic necrosis (arrows). There was no evidence of recurrence; the PSA level was 1.5 ng/mL. (C) One-year after ablation, the patient’s PSA level had increased to 4.3 ng/mL. Axial T2-weighted MRI scan and the ADC image shows a recurrent lesion (blue circles) in the right apical peripheral zone adjacent to the ablation scar. Targeted biopsy confirmed Gleason score 3+4 prostate cancer, which was classified as in-field recurrence of clinically significant prostate cancer and subsequently re-treated with TPLA. In summary, serial multiplanar MRI demonstrates treatment response after TPLA with post-ablation necrosis, followed by MRI-detected IFR confirmed with biopsy at 12-month follow-up. Multiparametric MRI was performed with a 3.0-T MRI scanner (Skyra; Siemens Healthineers) using T2-weighted, diffusion-weighted, and ADC sequences, with gadobenate dimeglumine contrast material administration (Bracco Diagnostics).

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Overview of the study design. (A) The fully automated deep learning framework was developed to estimate body composition (BC) (defined as subcutaneous adipose tissue [SAT] in liters; visceral adipose tissue [VAT] in liters; skeletal muscle [SM] in liters; SM fat fraction [SMFF] as a percentage; and intramuscular adipose tissue [IMAT] in deciliters) from MRI. The fully automated framework comprised one model (model 1) to quantify different BC measures (SAT, VAT, SM, SMFF, and IMAT) as three-dimensional (3D) measures from whole-body MRI scans. The second model (model 2) was trained to identify standardized anatomic landmarks along the craniocaudal body axis (z coordinate field), which allowed for subdividing the whole-body measures into different subregions typically examined on clinical routine MRI scans (chest, abdomen, and pelvis). (B) BC was quantified from whole-body MRI in over 66,000 individuals from two large population-based cohort studies, the UK Biobank (UKB) (36,317 individuals) and the German National Cohort (NAKO) (30,291 individuals). Bar graphs show age distribution by sex and cohort. BMI = body mass index. (C) After the performance assessment of the fully automated framework, the change in BC measures, distributions, and profiles across age decades were investigated. Age-, sex-, and height-adjusted body composition reference curves were calculated and made publicly available in a web-based z-score calculator (https://circ-ml.github.io).

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