Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523270
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Advanced Imaging Holistic Omics Biobank
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Advanced Imaging Holistic Omics Biobank
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 eg 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 500000 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
Detailed Description:
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 eg 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
In case of imaging clinical and laboratory examination performed at OSR these data will be automatically collected
Annual update is required by the study with the questionnaires and interviews performed with in site clinical visit telehealth or whenever no one of the previous method is feasible with telephonic call
During the annual follow-up clinical lab test and imaging data will be collected
If patients perform annual check-up at OSR it will ask to automatically update patients record with those information and results
Data collected and updated will be chosen according to the patients specific risk profile and the clinical indication to perform III level imaging
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 eg 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
In case of imaging clinical and laboratory examination performed at OSR these data will be automatically collected
Annual update is required by the study with the questionnaires and interviews performed with in site clinical visit telehealth or whenever no one of the previous method is feasible with telephonic call
During the annual follow-up clinical lab test and imaging data will be collected
If patients perform annual check-up at OSR it will ask to automatically update patients record with those information and results
Data collected and updated will be chosen according to the patients specific risk profile and the clinical indication to perform III level imaging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None