Recruiting

Renal Mass Biopsy

Sponsor:

Loyola University

Code:

NCT05728957

Conditions

Kidney Tumor

Renal Benign Neoplasm

Renal Malignant Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this clinical trial is to better tell apart whether kidney tumors are benign (not cancer) or malignant (cancer) based on a biopsy or imaging tests and ask patients how they feel about decisions they make about treatment of their kidney tumor.

The main objectives are:

To estimate and compare the diagnostic accuracy of renal mass biopsy alone, PEER (with renal mass biopsy), and 99mTc-sestamibi SPECT/CT (with renal mass biopsy for hot tumors) to differentiate malignant and benign renal tumors.

To estimate and compare the diagnostic accuracy of renal mass biopsy, PEER (with renal mass biopsy), and 99mTc-sestamibi SPECT/CT (with renal mass biopsy for hot tumors) to differentiate oncocytoma from chromophobe RCC.

Participants will be asked to complete survey questions related to their health and kidney tumor at the start and end of the study. These can be done on paper, electronically, or by telephone.

Conditions

Kidney Tumor

Renal Benign Neoplasm

Renal Malignant Tumor

Study ID

NCT05728957

Start date

Feb 1, 2023

Status verified date

Mar, 2025

Completion date

Dec, 2033

Anticipated

Primary completion date

Feb, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants diagnosed with a clinically localized (cT1) renal tumor ≤7cm in size with a solid component suspicious for malignancy based on cross-sectional imaging
  • Pre-existing CT images of the mass with and without contrast or planned CT to ensure both with and without contrast images of the mass have been obtained within a 365-day window
  • Participants must be greater than or equal to 18 years of age
  • Eligible or planned to undergo partial or radical nephrectomy as determined by primary urologist
  • Eligible or planned to receive renal mass biopsy as determined by primary urologist
  • Estimated glomerular filtration rate of ≥30 ml/min/1.73 m2 as calculated by the CKD-EPI (Chronic Kidney Disease-Epidemiology Collaboration) Equation

Exclusion Criteria:

  • Participants must not be pregnant (as determined by local policy by radiology / imaging center)
  • Participants must not have evidence of clinical nodal or distant metastasis.
  • Participants must not have had a history of other malignancy with concern for renal metastasis.
  • Participants must not have any known allergy to technetium or sestamibi.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Histologic Classification (malignant vs. benign) [ Time Frame: Until surgical extirpation or 1 year repeat biopsy ]

Central Contacts and Locations

Central contacts

Gopal N Gupta, MD

708-216-8467gogupta@lumc.edu

Agnes Natonton

708-327-3295anatont@luc.edu

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Agnes Natonton

708-327-3295anatont@luc.edu

More Information

Sponsor

Loyola University

Last update posted

Mar 19, 2025

Last verified

Mar, 2025

Keywords

  • Kidney Tumor
  • Survey Questions
  • Benign
  • Malignant
  • Renal Benign Neoplasm
  • Renal Malignant Tumor
  • Nuclear Imaging
  • Computed Tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2025-03-19.