Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334965
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-02-05
Brief Title:
Multi-modal Characterisation of Hepatocellular Carcinoma HCC Treated With Targeted Radionuclide Therapy TRT Prospective Interventional Multicentre National Cohort
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Multi-modal Characterisation of Hepatocellular Carcinoma HCC Treated With Targeted Radionuclide Therapy TRT Prospective Interventional Multicentre National Cohort
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPERANDI-HCC
Brief Summary:
OPERANDI project aims to address unmet clinical needs in the current management of advanced-stage HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence AI and data augmentation simultaneous PET-MRI imaging and novel approaches to increase patient selection and TARE efficacy genomic profiling radiopotentiators and new radionuclides The research aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients This cohort will be used to uncover relevant predictive signatures within the morphological functional and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 18F-Choline PET-MRI
Considering this global objective the objective of this clinical research protocol is to provide clinical molecular and imaging data in a prospective standardized study notably by performing systematic pretherapeutic and follow-up PET-MRI in patients with HCC treated with TARE
Considering this global objective the objective of this clinical research protocol is to provide clinical molecular and imaging data in a prospective standardized study notably by performing systematic pretherapeutic and follow-up PET-MRI in patients with HCC treated with TARE
Detailed Description:
Hepatocellular carcinoma HCC is the most common primary malignant liver tumors considered the sixth most common cancer and the third major cause of cancer-related death Its worldwide incidence is expected to increase in the future Additionally it shows marked intertumor and intratumor heterogeneity at the microscopic and molecular levels and there are currently no reliable imaging markers for predicting response to TARE
TARE is a highly advanced treatment that consists in intra-arterial injection of radioactive microspheres TARE is already approved for liver metastases and HCC in most countries So TARE for HCC is part of the therapeutic Armamentarium exerting antitumor effects based on radio-biological DNA damage and immunological mechanisms TARE using most currently 90Y-loaded microspheres has proven its non-inferiority with better tolerance and better tumor response in comparison with systemic treatments in patients with HCC
While highly promising patient stratification and early identification of responders are currently insufficient due to the lack of pertinent imaging biomarkers either non-invasive or invasive Furthermore prior therapy-induced DNA damages may lead to tumor resistance therefore reducing TARE efficacy Hence the absence of a personalized treatment strategy is an unmet need for patients with HCC This may result in survival disadvantage for non-responders who could benefit otherwise from early treatment change with expected more favorable outcomes
Simultaneous PET-MRI OPERANDI proposes a completely innovative and holistic approach via PET-MRI guided therapy The research hypothesis is that simultaneous PET-MRI imaging provides more robust non-invasive predictive biomarkers than classical approach and better correlation between quantification of radiation therapy dosimetry and clinical outcomes than PET-CT This requires technological development of PET-MRI with most methodological challenges being attenuation correction reducing the impact of organ motion due to respiration and cardiac motion and minimizing truncation and susceptibility artifacts
A PETMRI scan is a two-in-one test that combines images from a positron emission tomography PET scan and a magnetic resonance imaging MRI scan This new hybrid technology harnesses the strengths of PET and MRI to produce some of the most highly detailed images currently available MRI scans use a strong 15 to 3T for clinical use magnetic field to produce detailed morphologic images and some sequences provide functioning information such as diffusion-weighted dynamic contrast-enhanced MR elastography sequence PET scans use tracers according to the clinical indications to highlight metabolism changes In HCC the most common radiotracers are fluorodeoxyglucose FDG or Choline which detect metabolically active malignant lesions
OPERANDI project aims to address unmet clinical needs in the current management of HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence AI and data augmentation simultaneous PET-MRI imaging and novel approaches to increase patient selection and TARE efficacy genomic profiling radiopotentiators and new radionuclides Investigators aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients This cohort will be used to uncover relevant predictive signatures within the morphological functional and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous PET-MRI
Considering this global objective the objective of this clinical research protocol is to provide clinical molecular and imaging data in a prospective standardized study notably by performing systematic pretherapeutic and follow-up PET-MRI in patients with HCC treated with TARE
TARE is a highly advanced treatment that consists in intra-arterial injection of radioactive microspheres TARE is already approved for liver metastases and HCC in most countries So TARE for HCC is part of the therapeutic Armamentarium exerting antitumor effects based on radio-biological DNA damage and immunological mechanisms TARE using most currently 90Y-loaded microspheres has proven its non-inferiority with better tolerance and better tumor response in comparison with systemic treatments in patients with HCC
While highly promising patient stratification and early identification of responders are currently insufficient due to the lack of pertinent imaging biomarkers either non-invasive or invasive Furthermore prior therapy-induced DNA damages may lead to tumor resistance therefore reducing TARE efficacy Hence the absence of a personalized treatment strategy is an unmet need for patients with HCC This may result in survival disadvantage for non-responders who could benefit otherwise from early treatment change with expected more favorable outcomes
Simultaneous PET-MRI OPERANDI proposes a completely innovative and holistic approach via PET-MRI guided therapy The research hypothesis is that simultaneous PET-MRI imaging provides more robust non-invasive predictive biomarkers than classical approach and better correlation between quantification of radiation therapy dosimetry and clinical outcomes than PET-CT This requires technological development of PET-MRI with most methodological challenges being attenuation correction reducing the impact of organ motion due to respiration and cardiac motion and minimizing truncation and susceptibility artifacts
A PETMRI scan is a two-in-one test that combines images from a positron emission tomography PET scan and a magnetic resonance imaging MRI scan This new hybrid technology harnesses the strengths of PET and MRI to produce some of the most highly detailed images currently available MRI scans use a strong 15 to 3T for clinical use magnetic field to produce detailed morphologic images and some sequences provide functioning information such as diffusion-weighted dynamic contrast-enhanced MR elastography sequence PET scans use tracers according to the clinical indications to highlight metabolism changes In HCC the most common radiotracers are fluorodeoxyglucose FDG or Choline which detect metabolically active malignant lesions
OPERANDI project aims to address unmet clinical needs in the current management of HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence AI and data augmentation simultaneous PET-MRI imaging and novel approaches to increase patient selection and TARE efficacy genomic profiling radiopotentiators and new radionuclides Investigators aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients This cohort will be used to uncover relevant predictive signatures within the morphological functional and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous PET-MRI
Considering this global objective the objective of this clinical research protocol is to provide clinical molecular and imaging data in a prospective standardized study notably by performing systematic pretherapeutic and follow-up PET-MRI in patients with HCC treated with TARE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None