Clinical trial NCT06126159: MRI Functional Imaging Characteristics and Fat Quantification of CT-fat-free Renal Neoplasms: Relationships With Histological Classifications and Molecular Markers
Official title: MRI Functional Imaging Characteristics and Fat Quantification of CT-fat-free Renal Neoplasms: Relationships With Histological Classifications and Molecular Markers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Neoplasms
Keywords: kidney
angiomyolipoma
renal cell carcinoma
imaging characteristics
magnetic resonance imaging
immunohistochemistry stain
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 patient's 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 20 years old
2. Have renal parenchymal masses with no detectable intra-tumoral fat on computed tomography (CT)
3. Normal renal function (i.e.: estimated glomerular filtration rate ≧ 60 mL/min/1.73 m2)
4. No allergy history of iodinated contrast medium

Exclusion Criteria:

1. Pregnant or lactating woman
2. Withdrawal of informed consent
3. Those who have not completed MRI
4. Those who did not receive renal tumor biopsy

Primary outcomes:
measure: MR characteristics assessment- T2WI
timeFrame: 3 years
measure: MR characteristics assessment- ADC
timeFrame: 3 years
measure: MR characteristics assessment- IVIM
timeFrame: 3 years
Secondary outcomes:
measure: Immunohistochemistry (IHC) statin- mTOR
timeFrame: 3 years
measure: Immunohistochemistry (IHC) statin- Phospho-mTOR
timeFrame: 3 years
measure: Immunohistochemistry (IHC) statin- Rheb
timeFrame: 3 years
measure: Immunohistochemistry (IHC) statin- S6K
timeFrame: 3 years
measure: Immunohistochemistry (IHC) statin- pS6K
timeFrame: 3 years
measure: Quantitative Real-Time polymerase chain reaction (qPCR)
timeFrame: 3 years
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Li-Jen Wang
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Li-Jen Wang, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: