Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLoyola University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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).
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Until surgical extirpation or 1 year repeat biopsySecondary outcomes
1
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.
Time frame
30 days after surgical extirpation or 1 year repeat biopsy2
Non-diagnostic rate for renal mass biopsy
To estimate the non-diagnostic rate of renal mass biopsy.
Time frame
30 days after surgical extirpation or 1 year repeat biopsy3
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.
Time frame
30 days after surgical extirpation or 1 year repeat biopsySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov