Kidney NeoplasmsNCT06126159
MRI Functional Imaging Characteristics and Fat Quantification of CT-fat-free Renal Neoplasms: Relationships With Histological Classifications and Molecular Markers
A study testing multiparametric and fat-detection magnetic resonance imaging (MRI) in people with Kidney Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- multiparametric and fat-detection magnetic resonance imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Feb 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating woman
- Withdrawal of informed consent
- Those who have not completed MRI
- Those who did not receive renal tumor biopsy
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Kidney Neoplasms
- Being tested
- multiparametric and fat-detection magnetic resonance imaging (MRI)
- Keywords
- kidney, angiomyolipoma, renal cell carcinoma, imaging characteristics, magnetic resonance imaging, immunohistochemistry stain
- Medical subject headings
- Kidney Neoplasms, Angiomyolipoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiparametric and fat-detection magnetic resonance imaging (MRI)Diagnostic test
Differentiating of renal AMLs with minimal fat and RCCs
| Study group | Role | What they receive |
|---|---|---|
| multiparametric and fat-detection magnetic resonance imaging (MRI) | Experimental | detecting the small amount of fat with the use of fat-detecting pulse sequences on MRI Receives: Diagnostic Test: multiparametric and fat-detection magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR characteristics assessment- T2WI
T2-weighted images (T2WI)
Measured: 3 years
MR characteristics assessment- ADC
Apparent diffusion coefficient (ADC)
Measured: 3 years
MR characteristics assessment- IVIM
Intravoxel incoherent motion (IVIM)
Measured: 3 years
Secondary outcomes (6)
Immunohistochemistry (IHC) statin- mTOR
The IHC stains for protein reactions of total mTOR are analyzed using electronic files obtained from Aperio Digital pathology slide Scanner.
Measured: 3 years
Immunohistochemistry (IHC) statin- Phospho-mTOR
The IHC stains for protein reactions of Phospho-mTOR (pmTOR) are analyzed using electronic files obtained from Aperio Digital pathology slide Scanner.
Measured: 3 years
Immunohistochemistry (IHC) statin- Rheb
The IHC stains for protein reactions of Rheb are analyzed using electronic files obtained from Aperio Digital pathology slide Scanner.
Measured: 3 years
Immunohistochemistry (IHC) statin- S6K
The IHC stains for protein reactions of S6K are analyzed using electronic files obtained from Aperio Digital pathology slide Scanner.
Measured: 3 years
Immunohistochemistry (IHC) statin- pS6K
The IHC stains for protein reactions of pS6K are analyzed using electronic files obtained from Aperio Digital pathology slide Scanner.
Measured: 3 years
Quantitative Real-Time polymerase chain reaction (qPCR)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start11 Feb 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Jen Wang, Chang Gung Memorial Hospital
- Investigators
- Li-Jen Wang, M.D., M.P.H., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126159
- Sponsor's protocol ID
- 201802271A3
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to make individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Functional Imaging Characteristics and Fat Quantification of CT-fat-free Renal Neoplasms: Relationships With Histological Classifications and Molecular Markers
- ClinicalTrials.gov ID
- NCT06126159
- Acronym / sponsor ID
- 201802271A3
- Conditions
- Kidney Neoplasms
- Keywords
- kidney, angiomyolipoma, renal cell carcinoma, imaging characteristics, magnetic resonance imaging, immunohistochemistry stain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multiparametric and fat-detection magnetic resonance imaging (MRI) | Experimental | Diagnostic Test: multiparametric and fat-detection magnetic resonance imaging (MRI)detecting the small amount of fat with the use of fat-detecting pulse sequences on MRI |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant or lactating woman
- Withdrawal of informed consent
- Those who have not completed MRI
- Those who did not receive renal tumor biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multiparametric and fat-detection magnetic resonance imaging (MRI)Differentiating of renal AMLs with minimal fat and RCCs | Diagnostic test | multiparametric and fat-detection magnetic resonance imaging (MRI) |
Primary outcome
MR characteristics assessment- T2WI
Time frame: 3 years
T2-weighted images (T2WI)
MR characteristics assessment- ADC
Time frame: 3 years
Apparent diffusion coefficient (ADC)
MR characteristics assessment- IVIM
Time frame: 3 years
Intravoxel incoherent motion (IVIM)
6 secondary outcomes
Immunohistochemistry (IHC) statin- mTOR
Time frame: 3 years
Immunohistochemistry (IHC) statin- Phospho-mTOR
Time frame: 3 years
Immunohistochemistry (IHC) statin- Rheb
Time frame: 3 years
Immunohistochemistry (IHC) statin- S6K
Time frame: 3 years
Immunohistochemistry (IHC) statin- pS6K
Time frame: 3 years
Quantitative Real-Time polymerase chain reaction (qPCR)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. Plan to make individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Jen Wang, M.D., M.P.H. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multiparametric and fat-detection magnetic resonance imaging (MRI) in people with Kidney Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MR characteristics assessment- T2WI (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.