NCT05728957 Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors
| NCT ID | NCT05728957 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Loyola University |
| Condition | Kidney Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2033-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-02-01 with a primary completion date of 2033-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Hiten D Patel, MD, MPH
PRINCIPAL INVESTIGATOR
Loyola University
Frequently Asked Questions
Who can join the NCT05728957 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05728957 currently recruiting?
Yes, NCT05728957 is actively recruiting participants. Contact the research team at gogupta@lumc.edu for enrollment information.
Where is the NCT05728957 trial being conducted?
This trial is being conducted at Maywood, United States.
Who is sponsoring the NCT05728957 clinical trial?
NCT05728957 is sponsored by Loyola University. The principal investigator is Hiten D Patel, MD, MPH at Loyola University. The trial plans to enroll 100 participants.
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