Medical imaging clinical trials unit: a professional need

Purpose To design and describe a management and control tool and the human resources needed to efficiently manage the imaging process within clinical trials for a better quality of care for the patient. Methods A unit was created to efficiently organise the participation of our Medical Imaging Department in clinical trials. This entity was defined and monitored using a customized, flexible and modular software package that provides the necessary information to execute and monitor requests (appointments, protocols, reports, complaints, billing). Various indicators of activity and professional satisfaction were parameterised. Results From 2016 to 2020, 367 trials were participated and monitored, 50% of all the hospital clinical trials. The budget of the Medical Imaging Department grew by 47% in this period. The coordination with other departments and principal investigators improved, as shown by surveys (62% fluid and 38% very fluid), with a high perception of collaboration (86%). Conclusions The implementation of a Medical Imaging Clinical Trials Unit involve identifying the tasks, personnel, organisational needs, workflow, monitoring and invoicing. The creation of this Unit has improved the control and traceability of clinical trials within the Department.Peer ReviewedPostprint (published version

Quantitative approach to assist neuroblastoma assessment by measuring I-123 mIBG uptake in scintigraphic images

Whole-body 123I-Metaiodobenzylguanidine (mIBG) scintigraphy is used as the primary image modality in neuroblastoma detection. It is the most sensitive and specific method for staging and response evaluation. Validated semi-quantitative scoring methods with low interobserver variability and high reproducibility have shown to be indispensable for the evaluation of response to therapy. However, low resolution, noise and acquisition difficulties, specially in children, make low definition scans. These facts increase observer dependent interpretations that limit assessment and complicate to put a scoring method succesfully into practice. It is essential to have an objective and reliable measure of response to test the activity of therapies. In this paper we propose the use of a quantitative observer-independent measurement of the strength of uptake to be used as an additional tool for assisting the International Society of Paediatric Oncology Europe Neuroblastoma Group (SIOPEN) semi-quantitative scoring method. This is the scoring method recommended by the SIOPEN Nuclear Medicine and Physics Committee, in collaborative work with the Children’s Oncology Group, as the standard one for acquiring and reporting diagnostic paediatric mIBG scans across Europe. Our proposed method is based on the ratio between the amount of specific uptake at tumours and the amount of non-specific uptake at SIOPEN anatomical sectors which has shown to be constant in all the scans of the patients.This work has been supported by "Ayudas para Actividades Preparatorias de Proyectos Coordinados entre Investigadores de la Universitat Politecnica de Valencia e Investigadores del Hospital Universitario y Politecnico La Fe", II Call, 2013, AUTOSCOREMIBG project. The authors are very grateful to the referees for their useful comments.Martínez Díaz, R.; Balaguer Guill, J.; Sánchez Ruiz, LM.; Bello Arques, P.; Castel, V.; Rivas Sanchez, A.; Cañete Nieto, A.... (2015). Quantitative approach to assist neuroblastoma assessment by measuring I-123 mIBG uptake in scintigraphic images. Image Analysis and Stereology. 34(2):135-144. doi:10.5566/ias.1219S13514434

Same-day comparative protocol PET/CT-PET/MRI [68 Ga]Ga-DOTA-TOC in paragangliomas and pheochromocytomas: an approach to personalized medicine

Abstract Background PET/MRI is an emerging imaging modality which enables the evaluation and quantification of biochemical processes in tissues, complemented with accurate anatomical information and low radiation exposure. In the framework of theragnosis, PET/MRI is of special interest due to its ability to delineate small lesions, adequately quantify them, and therefore to plan targeted therapies. The aim of this study was to validate the diagnostic performance of [68 Ga]Ga-DOTA-TOC PET/MRI compared to PET/CT in advanced disease paragangliomas and pheochromocytomas (PGGLs) to assess in which clinical settings, PET/MRI may have a greater diagnostic yield. Methods We performed a same-day protocol with consecutive acquisition of a PET/CT and a PET/MRI after a single [68 Ga]Ga-DOTA-TOC injection in 25 patients. Intermodality agreement, Krenning Score (KS), SUVmax (Standard Uptake Value), target-to-liver-ratio (TLR), clinical setting, location, and size were assessed. Results The diagnostic accuracy with PET/MRI increased by 14.6% compared to PET/CT especially in bone and liver locations (mean size of new lesions was 3.73 mm). PET/MRI revealed a higher overall lesion uptake than PET/CT (TLR 4.12 vs 2.44) and implied an upward elevation of the KS in up to 60% of patients. The KS changed in 30.4% of the evaluated lesions (mean size 11.89 mm), in 18.4% of the lesions it increased from KS 2 on PET/CT to a KS ≥ 3 on PET/MRI and 24.96% of the lesions per patient with multifocal disease displayed a KS ≥ 3 on PET/MR, that were not detected or showed lower KS on PET/CT. In 12% of patients, PET/MRI modified clinical management. Conclusions PET/MRI showed minor advantages over conventional PET/CT in the detection of new lesions but increased the intensity of SSRs expression in a significant number of them, opening the door to select which patients and clinical settings can benefit from performing PET/MRI