Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-11-06
Brief Title:
MRI Functional Imaging Characteristics and Fat Quantification of CT-fat-free Renal Neoplasms Relationships With Histological Classifications and Molecular Markers
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
MRI Functional Imaging Characteristics and Fat Quantification of CT-fat-free Renal Neoplasms Relationships With Histological Classifications and Molecular Markers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The knowledge of the histological diagnosis and its subtype of a renal parenchymal tumor is important for determine whether the choice of a specific regimen of chemotherapy target therapy and immunotherapy could be suitable and effective for treating this tumor Computed tomography CT has been considered as an excellent imaging modality for detecting intra-tumoral fat and most of renal angiomyolipomas AML could be thus confidently diagnosed on computed tomography by showing intra-tumoral fat However if a renal parenchymal tumor has no detectable fat in the tumor on computed tomography there is a long list of its diagnosis including benign neoplasms as angiomyolipoma with minimal fat oncocytoma metanephric adenoma etc epitheloid angiomyolipoma eAML malignant potential malignant neoplasms as renal cell carcinoma RCC sarcoma malignant eAML etc Furthermore there are three kinds of anticancer drug antiangiogenetic drug mammalian target of rapamycin inhibitors immune modulators and whether the anticancer drug is effective mainly depending on subtypes of RCCs Nonetheless computed tomography could not reliably differentiate histological types of renal parenchymal masses except renal AMLs with abundant fat Therefore for patients without established diagnoses by imaging examinations further biopsy of the renal tumor is usually mandatory to validate the histological diagnosis and subtype Thus this study plans to enroll 60 patients with renal parenchymal masses which show no intra-tumoral fat on computed tomography All enrolled patients will undergo multiparametric and fat-detection magnetic resonance imaging MRI
Detailed Description:
Multiparametric MRI includes not only conventional T1-weighted and T2-weighted images but also diffusion weighted images and dynamic contrast enhanced images Fat-detection MRI include fat-suppressed images by frequency selection out-of-phase images compared with in-phase image and fat quantification pulse sequence for determining the presence or absence of intra-tumoral fat as well as measuring fat amount We will record MRI characteristics of the renal parenchymal tumors of the patients If the patients undergo further biopsy for establishing histological diagnoses and subtypes after MRI examination the specimens of the renal tumor obtained from biopsy will be further analyzed by immunohistochemistry stain IHC quantitative real-time polymerase chain reaction qPCR and western blot after obtainment of the patients informed consent The MRI characteristics of the renal parenchymal tumors of the patients will be then correlated with histological examination IHC qPCR and western blot examinations of the tumors We will then use univariate and multivariate analyses to determine whether MRI characteristics are useful as imaging surrogates for predicting biomarkers as histological diagnosis subtypes IHC qPCR and western blot results
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