Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243250
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-17
Brief Title:
Hyperpolarized 13C-MRI and Metabolomics for Immune-related Adverse Events
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Integrated Precision Imaging for Immune-related Adverse Events Hyperpolarized 13C-MRI and Metabolomics
Status:
RECRUITING
Status Verified Date:
2024-01
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:
DNP_irAE
Brief Summary:
This project investigates immune-related adverse events irAEs in cancer patients treated with immune checkpoint inhibitors ICIs focusing on metabolic changes It explores how glucose metabolism in the spleen which mirrors immune activity might predict irAEs Using advanced imaging like hyperpolarized HP 13C-MRI and metabolomics the study aims to detect metabolic flux in the spleen potentially offering early prediction and risk categorization of irAEs The 3-year study will involve 30 cancer patients on ICIs comparing those with and without irAEs It hypothesizes that splenic metabolic alterations seen in HP 13C-MRI can forecast and categorize irAE severity improving our understanding of irAEs and potentially guiding new treatments
Detailed Description:
Immune-related adverse events irAEs have become clinical challenges with the exponential increase in the use of immune checkpoint inhibitors ICIs in medical oncology irAEs can be fulminant and fatal requiring personalized management Early prediction and accurate risk categorization of irAEs are urgently needed to tailor patient management Glucose metabolism in the spleen may reflect immune activity and has been used to predict tumor response to ICIs Since the underlying mechanism of irAEs is similar to ICIs tumor response the splenic metabolism is a potential biomarker for irAEs
This project is novel because it aims to investigate irAEs from the perspective of metabolism by integrating hyperpolarized HP 13C-MRI metabolomics and MR fingerprinting MRF HP 13C-MRI is a new non-invasive real-time dynamic imaging technique used to detect the metabolic flux in vivo Dynamic nuclear polarization DNP is a hyperpolarization technique that increases the signal of 13C-labeled probes by up to 50000-fold With DNP 1-13Cpyruvate can be used to probe various metabolic pathways including its conversion to lactate anaerobic glycolysis alanine transamination and bicarbonate indirect marker for TCA cycle These specific metabolic alterations have been used to characterize the functions of immune cells thus they may also reflect the splenic immune activity in patients with irAEs Additionally NMR-based metabolomics analyses of patients serum and urine will provide a more global view of metabolic changes of whole human body Furthermore the observed metabolic alterations can be translated into multiparametric tissue properties obtained by MRF
The investigator design a 3-year project with a non-randomized two group assignment observational study design This research will include 30 cancer patients receiving ICIs Twenty patients experiencing acute phase irAEs grade 2 or higher and 10 patients not experiencing irAEs after 14 weeks of treatment will be recruited for this prospective single institutional study A dedicated multidiscipline immune-oncologic board will screen patients who develop irAEs which include colitis endocrinopathy hepatitis pneumonitis and skin toxicity The diagnosis of the irAEs is determined by clinical history laboratory values standard-of-care imaging and histopathologic features when biopsy is necessary Participants eligible for this study will undergo investigative exams including HP 13C-MRI metabolomics and MRF
The investigator hypothesize that the spleen immune activity interrogated using HP 13C-MRI can predict the occurrence of irAEs Additionally the level of splenic metabolic alterations based on HP 13C-MRI will be correlated to the clinical severity of irAEs providing additional risk categorization for irAEs Moreover by establishing metabolic information and tissue characteristics obtained by MRF the dynamic changes of immune activity may be monitored by the quantifiable and reproducible tissue properties Finally by combining HP 13C-MRI and metabolomics the investigator will have a better understanding of the pathophysiology of irAEs from the perspective of metabolism which may lead to the development of new therapy
This project is novel because it aims to investigate irAEs from the perspective of metabolism by integrating hyperpolarized HP 13C-MRI metabolomics and MR fingerprinting MRF HP 13C-MRI is a new non-invasive real-time dynamic imaging technique used to detect the metabolic flux in vivo Dynamic nuclear polarization DNP is a hyperpolarization technique that increases the signal of 13C-labeled probes by up to 50000-fold With DNP 1-13Cpyruvate can be used to probe various metabolic pathways including its conversion to lactate anaerobic glycolysis alanine transamination and bicarbonate indirect marker for TCA cycle These specific metabolic alterations have been used to characterize the functions of immune cells thus they may also reflect the splenic immune activity in patients with irAEs Additionally NMR-based metabolomics analyses of patients serum and urine will provide a more global view of metabolic changes of whole human body Furthermore the observed metabolic alterations can be translated into multiparametric tissue properties obtained by MRF
The investigator design a 3-year project with a non-randomized two group assignment observational study design This research will include 30 cancer patients receiving ICIs Twenty patients experiencing acute phase irAEs grade 2 or higher and 10 patients not experiencing irAEs after 14 weeks of treatment will be recruited for this prospective single institutional study A dedicated multidiscipline immune-oncologic board will screen patients who develop irAEs which include colitis endocrinopathy hepatitis pneumonitis and skin toxicity The diagnosis of the irAEs is determined by clinical history laboratory values standard-of-care imaging and histopathologic features when biopsy is necessary Participants eligible for this study will undergo investigative exams including HP 13C-MRI metabolomics and MRF
The investigator hypothesize that the spleen immune activity interrogated using HP 13C-MRI can predict the occurrence of irAEs Additionally the level of splenic metabolic alterations based on HP 13C-MRI will be correlated to the clinical severity of irAEs providing additional risk categorization for irAEs Moreover by establishing metabolic information and tissue characteristics obtained by MRF the dynamic changes of immune activity may be monitored by the quantifiable and reproducible tissue properties Finally by combining HP 13C-MRI and metabolomics the investigator will have a better understanding of the pathophysiology of irAEs from the perspective of metabolism which may lead to the development of new therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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