Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors (BIOPSy)

March 17, 2025 updated by: Hiten Patel, Loyola University

A Prospective Diagnostic Cohort Study to Compare the Accuracy of Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The investigators are asking the participant to take part in this research study because they were diagnosed with a kidney tumor. Kidney tumors can be benign (not cancer) or malignant (cancer) and the investigators hope to figure out how to better tell them apart before surgery or other treatment.

The investigators hope 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.

Biopsy is a standard test to determine if a tumor is cancerous before making a treatment decision.

The imaging test (99mTc-sestamibi SPECT/CT) the investigators are studying has been studied before and found to help identify benign kidney tumors. It is not approved by the Food and Drug Administration (FDA) for imaging kidney tumors. It is FDA approved for use in imaging the heart and breasts. It has been studied for use in parathyroid gland imaging.

The participant will be asked to complete survey questions related to their health and kidney tumor at the start and end of the study. The participant will receive a 99mTc-sestamibi SPECT/CT scan (if they have not had one already) for research purposes. The participant will receive a biopsy of the kidney tumor (if they have not had one already) as part of their routine clinical care. The participant will then receive treatment of the kidney tumor as determined by consultation with their doctor.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Name: Gopal N Gupta, MD
Phone Number: 708-216-8467
Email: gogupta@lumc.edu

Study Contact Backup

Name: Agnes Natonton
Phone Number: 708-327-3295
Email: anatont@luc.edu

Study Locations

United States
- Illinois
  - Maywood, Illinois, United States, 60153
    - Recruiting
    - Loyola University Medical Center
    - Contact:
      
      Agnes Natonton
      
      Phone Number: 708-327-3295
      
      Email: anatont@luc.edu
    - Contact:
      
      Gopal N Gupta, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Participants will be 18 years of age and older, male or female and diagnosed with a kidney tumor. Kidney tumors can be benign (not cancer) or malignant (cancer).

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histologic Classification (malignant vs. benign) Time Frame: Until surgical extirpation or 1 year repeat biopsy	The classification of each tumor as malignant or benign by the diagnostic approaches of interest will be compared to the primary endpoint of malignant vs. benign based on surgical pathology or biopsy.	Until surgical extirpation or 1 year repeat biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histologic Classification (RCC vs. oncocytoma) Time Frame: 30 days after surgical extirpation or 1 year repeat biopsy	The classification of each tumor as RCC or oncocytoma by the diagnostic approaches of interest will be compared to the primary endpoint of RCC vs. oncocytoma based on surgical pathology or biopsy.	30 days after surgical extirpation or 1 year repeat biopsy
Non-diagnostic rate for renal mass biopsy Time Frame: 30 days after surgical extirpation or 1 year repeat biopsy	To estimate the non-diagnostic rate of renal mass biopsy.	30 days after surgical extirpation or 1 year repeat biopsy
Patient-reported measures/outcomes related to mental health, physical health, distress, and regret Time Frame: 30 days after surgical extirpation or 1 year repeat biopsy	To describe patient-reported measures/outcomes related to mental health, physical health, distress, and regret for the diagnosis and management of renal tumors.	30 days after surgical extirpation or 1 year repeat biopsy

Collaborators and Investigators

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

Sponsor

Loyola University

Investigators

Principal Investigator: Hiten D Patel, MD, MPH, Loyola University
Principal Investigator: Gopal N Gupta, MD, Loyola University

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 1, 2023

Primary Completion (Estimated)

February 1, 2033

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria