NCT05728957 · Loyola University
Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors
(BIOPSy)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Maywood, Illinois
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2025 · Source of record for eligibility and locations