SPECT/CT for the Characterization of Renal Masses
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|ClinicalTrials.gov Identifier: NCT03996850|
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : July 23, 2020
|Condition or disease||Intervention/treatment|
|Kidney Neoplasm Renal Mass||Procedure: Computed Tomography Other: Questionnaire Administration Procedure: Single Photon Emission Computed Tomography Radiation: Technetium Tc-99m Sestamibi|
I. To determine the impact of technetium Tc-99m sestamibi (MIBI) SPECT/CT on patient management decisions.
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.
I. Evaluate the mitochondria content in tumors that had positive MIBI SPECT/CT findings.
Patients receive technetium Tc-99m sestamibi intravenously (IV) then undergo SPECT/CT.
After completion of study, patients are followed up for 6 months.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making|
|Actual Study Start Date :||December 7, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 2022|
Health service research (MIBI SPECT/CT, questionnaire)
Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
Procedure: Computed Tomography
Other: Questionnaire Administration
Procedure: Single Photon Emission Computed Tomography
Radiation: Technetium Tc-99m Sestamibi
- Change in patient management decision [ Time Frame: 6 months ]Assessed with post-test, physician counseling.
- Decision making based on tumor size [ Time Frame: 6 months ]Could be differentially impacted in two strata, tumors 1.5-3.0 cm and 3.1-5.0 cm.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996850
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Brian Shuch 310-794-7700 BShuch@mednet.ucla.edu|
|Principal Investigator: Brian Shuch|
|Principal Investigator:||Brian Shuch||UCLA / Jonsson Comprehensive Cancer Center|