Loyola University Medical Center
Maywood, Illinois, 60153, United States
Location status: Recruiting
NCT Number: NCT05728957
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Maywood, Illinois, 60153, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 30 days after surgical extirpation or 1 year repeat biopsy
To estimate the non-diagnostic rate of renal mass biopsy.
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.
Contact information is provided by the study sponsor or research team.
Agnes Natonton
CONTACT
Gopal N Gupta, MD
CONTACT
Loyola University
Other
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
Acronym: BIOPSy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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