Kidney TumorBIOPSyNCT05728957
Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors
An observational study of Kidney Tumor and Renal Benign Neoplasm, run by Loyola University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Tumor, Renal Benign Neoplasm, Renal Malignant Tumor
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Gopal N Gupta, MD
Agnes Natonton, 708-327-3295, anatont@luc.edu
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Kidney Tumor, Renal Benign Neoplasm, Renal Malignant Tumor
- Keywords
- Kidney Tumor, Survey Questions, Benign, Malignant, Renal Benign Neoplasm, Renal Malignant Tumor, Nuclear Imaging, Computed Tomography
- Medical subject headings
- Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic Classification (malignant vs. benign)
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.
Measured: Until surgical extirpation or 1 year repeat biopsy
Secondary outcomes (3)
Histologic Classification (RCC vs. oncocytoma)
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.
Measured: 30 days after surgical extirpation or 1 year repeat biopsy
Non-diagnostic rate for renal mass biopsy
To estimate the non-diagnostic rate of renal mass biopsy.
Measured: 30 days after surgical extirpation or 1 year repeat biopsy
Patient-reported measures/outcomes related to mental health, physical health, distress, and regret
To describe patient-reported measures/outcomes related to mental health, physical health, distress, and regret for the diagnosis and management of renal tumors.
Measured: 30 days after surgical extirpation or 1 year repeat biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Feb 2023
- Primary completionFeb 2033 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiten Patel, Loyola University
- Investigators
- Hiten D Patel, MD, MPH, Principal investigator, Loyola UniversityGopal N Gupta, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728957
- Sponsor's protocol ID
- 215278
- Acronym
- BIOPSy
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05728957
- Acronym / sponsor ID
- BIOPSy / 215278
- Conditions
- Kidney Tumor, Renal Benign Neoplasm, Renal Malignant Tumor
- Keywords
- Kidney Tumor, Survey Questions, Benign, Malignant, Renal Benign Neoplasm, Renal Malignant Tumor, Nuclear Imaging, Computed Tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Feb 2033 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Histologic Classification (RCC vs. oncocytoma)
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hiten D Patel, MD, MPH principal investigator
Loyola University
Gopal N Gupta, MD principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Tumor and Renal Benign Neoplasm, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gopal N Gupta, MD (708-216-8467, gogupta@lumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic Classification (malignant vs. benign) (time frame: Until surgical extirpation or 1 year repeat biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.