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

March 18, 2026 updated by: Li-Jen Wang, Chang Gung Memorial Hospital
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Taoyuan District, Taiwan, Taiwan, 333
        • Li-Jen Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: multiparametric and fat-detection magnetic resonance imaging (MRI)
detecting the small amount of fat with the use of fat-detecting pulse sequences on MRI
Diagnostic test: multiparametric and fat-detection magnetic resonance imaging (MRI)
Differentiating of renal AMLs with minimal fat and RCCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MR characteristics assessment- T2WI
Time Frame: 3 years
T2-weighted images (T2WI)
3 years
MR characteristics assessment- ADC
Time Frame: 3 years
Apparent diffusion coefficient (ADC)
3 years
MR characteristics assessment- IVIM
Time Frame: 3 years
Intravoxel incoherent motion (IVIM)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
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 years
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.
3 years
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.
3 years
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.
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Li-Jen Wang, M.D., M.P.H., Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201802271A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Plan to make individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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