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临床试验/NCT06523270
NCT06523270招募中不适用

Advanced Imaging Holistic Omics Biobank

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2024年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50,000
试验地点
1
主要终点
a large scale multiomics archive of patients submitted to advanced imaging studies to support a wide range of research intended to identify imaging signature able to improve the prevention, diagnosis and treatment of disease

研究概览

简要总结

Imaging methods today represent the pillar of prevention, diagnosis, patients monitoring and treatment. Improvement in technology led the development of increasingly high-performance scanners whose potential has not yet been fully explored. In particular, recently introduced photon counting CT scanner and new high filed MRI offers a lake of latent information derived from the images (e.g. spectral data from CT) of potentially great interest and potentially able to provide new insight but that are currently mostly unexplored .These features are also called "opportunist features" because they are in each exam and can be freely derived from images without changing the study protocol used for clinical practice examination but extracted a posteriori from the images representing a precious source of deep characterization of the patients, equally or even more than a genomic analysis, with possible high relevance in the field of screening and prevention, being able to contribute to defining signatures indicating a particular risk of remotely developing a specific pathological condition. The prospective collection of clinical and imaging data from subjects undergoing diagnostic tests with advanced technology has the potential to increase knowledge of the pathophysiological mechanisms of different pathological conditions, to explore and validate the diagnostic-predictive value of opportunistic features not currently used in practice clinical, to increase the diagnostic and prognostic accuracy of CT and MRI examinations and to provide a unique pool for scientific research. Previous relevant experience was conducted in the United Kingdom (UK biobank) where data from over 500,000 patients have been collected in the last 10 years, providing an enormous pool for spontaneous and funded scientific research. This project (UK biobank), although of enormous scientific value, is currently obsolete in terms of the imaging technology used.

详细描述

The present study is a observational prospective single center study aimed to build a large-scale multiomic database of patients submitted to advanced imaging study performed Photon Counting TC (Neaotom Alpha, Siemens) and 3T Magnetic Resonance Imaging (MR 7700, Philips).

Consecutive adult patients submitted to the aforementioned imaging modality will be enrolled.

For the enrolled patients imaging raw data will be stored additionally to conventional images, routinely stored for legal requirements.

At the time of enrollment clinical, demographic and lab test will be collected as well as results from genetic test if available, and related previous imaging study (e.g. mammography in patients submitted to whole body MRI or breast MRI, colonscopy in patients submitted to abdominal CT or MRI).

For patients candidate to imaging examination using contrast media at the time of needle position for contrast administration a blood sample will be collected for lab test analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult subjects (>18 y.o.) submitted to Computed Tomography (CT) using Photon Counting CT scanner (Neaotom Alpha, Siemens) and Magnetic Resonance (MRI) exams acquired with 3T scanner (MR 7700, Philips) for examination required for clinical practice or for clinical trials at the IRCCS San Raffaele Hospital who signe an Informed Consent authorizing data collection.

排除标准

  • Absent informed consent signed

研究组 & 干预措施

prospective cohort

All adult (≥18 y.o) subjects (until 50000 individuals) presenting to the U.O of Radiologia DiMer "Advanced Imaging for Personalized Medicine" to be submitted to imaging study on advanced scanner

干预措施: Computed Tomography (CT) using Photon Counting CT scanner (Neaotom Alpha, Siemens) and Magnetic Resonance (MRI) (Radiation)

结局指标

主要结局

a large scale multiomics archive of patients submitted to advanced imaging studies to support a wide range of research intended to identify imaging signature able to improve the prevention, diagnosis and treatment of disease

时间窗: Follow-up collection yearly for 10 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Esposito

Professor

IRCCS San Raffaele

研究点 (1)

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