UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
NCT Number: NCT03996850
This trial studies how well technetium Tc-99m sestamibi single-photon emission computed tomography/computed tomography (SPECT/CT) works on clinical decision making in patients with kidney tumors. Diagnostic procedures, such as technetium Tc-99m sestamibi SPECT/CT may be a less invasive way to check for kidney tumors.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Los Angeles, California, 90095, United States
PRIMARY OBJECTIVES:
I. To determine the impact of technetium Tc-99m sestamibi (MIBI) SPECT/CT on patient management decisions.
SECONDARY OBJECTIVES:
I. To evaluate the impact of MIBI SPECT/CT on patient management decisions for tumors 1.5-3.0 cm and 3.1-5.0 cm.
II. To assess the impact of MIBI SPECT/CT on decisional conflict score. III. To assess the impact of MIBI SPECT/CT on physician management recommendation.
IV. To evaluate the sensitivity and specificity of MIBI SPECT/CT for the identification of an oncocytic renal mass (oncocytoma, chromophobe, and hybrid oncocytic tumor) with respect to tumor histology identified by renal mass biopsy or surgical resection.
V. To compare the specificity of MIBI SPECT/CT with conventional cross-sectional imaging in predicting an oncocytic renal mass.
VI. To assess the correlation between MIBI SPECT/CT outcomes to final treatment decisions.
EXPLORATORY OBJECTIVES:
I. Evaluate the mitochondria content in tumors that had positive MIBI SPECT/CT findings.
OUTLINE:
Patients receive technetium Tc-99m sestamibi intravenously (IV) then undergo SPECT/CT.
After completion of study, patients are followed up for 6 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo SPECT/CT
Other names: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Ancillary studies
Undergo SPECT/CT
Other names: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
Given IV
Other names: Cardiolite, Miraluma, Tc 99m Sestamibi, Tc-99m MIBI, Tc99m Sestamibi
Time frame: 6 months
Assessed with post-test, physician counseling.
Time frame: 6 months
Could be differentially impacted in two strata, tumors 1.5-3.0 cm and 3.1-5.0 cm.
Jonsson Comprehensive Cancer Center
Other
SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making
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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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