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NCT Number: NCT06126159

MRI Functional Imaging Characteristics and Fat Quantification of CT-fat-free Renal Neoplasms: Relationships With Histological Classifications and Molecular Markers

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).

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Key information

Conditions

Kidney Neoplasms Adenocarcinoma Angiomyolipoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Perivascular Epithelioid Cell Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Li-Jen Wang

Taoyuan, Taiwan, 333

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant or lactating woman
  • Withdrawal of informed consent
  • Those who have not completed MRI
  • Those who did not receive renal tumor biopsy

Treatment and study plan

multiparametric and fat-detection magnetic resonance imaging (MRI)

Diagnostic Test

Differentiating of renal AMLs with minimal fat and RCCs

Primary outcomes

  1. MR characteristics assessment- T2WI

    Time frame: 3 years

    T2-weighted images (T2WI)

  2. MR characteristics assessment- ADC

    Time frame: 3 years

    Apparent diffusion coefficient (ADC)

  3. MR characteristics assessment- IVIM

    Time frame: 3 years

    Intravoxel incoherent motion (IVIM)

Secondary outcomes

  1. Immunohistochemistry (IHC) statin- mTOR

    Time frame: 3 years

    The IHC stains for protein reactions of total mTOR are analyzed using electronic files obtained from Aperio Digital pathology slide Scanner.

  2. Immunohistochemistry (IHC) statin- Phospho-mTOR

    Time frame: 3 years

    The IHC stains for protein reactions of Phospho-mTOR (pmTOR) are analyzed using electronic files obtained from Aperio Digital pathology slide Scanner.

  3. Immunohistochemistry (IHC) statin- Rheb

    Time frame: 3 years

    The IHC stains for protein reactions of Rheb are analyzed using electronic files obtained from Aperio Digital pathology slide Scanner.

  4. Immunohistochemistry (IHC) statin- S6K

    Time frame: 3 years

    The IHC stains for protein reactions of S6K are analyzed using electronic files obtained from Aperio Digital pathology slide Scanner.

  5. Immunohistochemistry (IHC) statin- pS6K

    Time frame: 3 years

    The IHC stains for protein reactions of pS6K are analyzed using electronic files obtained from Aperio Digital pathology slide Scanner.

  6. Quantitative Real-Time polymerase chain reaction (qPCR)

    Time frame: 3 years

    We extract RNA from tumor cells using RNeasy Mini Kit (Qiagen), according to the manufacturer's protocol and reverse transcription of RNA into cDNA is done using with PrimeScript TM RT reagent kit (Takara Bio Inc.), followed by amplified by polymerase chain reaction (PCR) using the SYBR Green SuperMix (BioRad, Hercules, CA).

    The quantitative real-time PCR (qPCR) test including primer sequences of the PI3K/AKT/mTOR pathway genes including Phosphatase and tensin homolog (PTEN), mTOR, ribosomal protein S6 kinase B1 (S6K1), Ras Homolog, MTORC1 Binding (RHEB) and Eukaryotic translation initiation factor 4E-binding protein 1 (4EBP1) genes are analyzed.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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