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

NCT06126159 | Active Not Recruiting

• 1 other identifier: 201802271A3
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Kidney Neoplasms

Keywords

kidney; angiomyolipoma; renal cell carcinoma; imaging characteristics; magnetic resonance imaging; immunohistochemistry stain

Outcome Measures

Primary Outcomes (3)

• MR characteristics assessment- T2WI

  T2-weighted images (T2WI)

  3 years

• MR characteristics assessment- ADC

  Apparent diffusion coefficient (ADC)

  3 years

• MR characteristics assessment- IVIM

  Intravoxel incoherent motion (IVIM)

  3 years

Secondary Outcomes (6)

• Immunohistochemistry (IHC) statin- mTOR

  3 years

• Immunohistochemistry (IHC) statin- Phospho-mTOR

  3 years

• Immunohistochemistry (IHC) statin- Rheb

  3 years

• Immunohistochemistry (IHC) statin- S6K

  3 years

• Immunohistochemistry (IHC) statin- pS6K

  3 years

Study Arms (1)

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

Diagnostic Test: multiparametric and fat-detection magnetic resonance imaging (MRI)

Interventions

multiparametric and fat-detection magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

Differentiating of renal AMLs with minimal fat and RCCs

multiparametric and fat-detection magnetic resonance imaging (MRI)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Li-Jen Wang

Taoyuan District, Taiwan, 333, Taiwan

Location

MeSH Terms

Conditions

Kidney Neoplasms; Angiomyolipoma; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Li-Jen Wang, M.D., M.P.H.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Imaging Department Director

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: February 11, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)