SPECT/CT for the Characterization of Renal Masses

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.

• Computed Tomography (Procedure), also known as CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography: Undergo SPECT/CT
• Questionnaire Administration (Other): Ancillary studies
• Single Photon Emission Computed Tomography (Procedure), also known as 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: Undergo SPECT/CT
• Technetium Tc-99m Sestamibi (Radiation), also known as Cardiolite, Miraluma, Tc 99m Sestamibi, Tc-99m MIBI, Tc99m Sestamibi: Given IV

Primary outcomes

• Change in patient management decision [6 months]: Assessed with post-test, physician counseling.

Secondary outcomes

• Decision making based on tumor size [6 months]: Could be differentially impacted in two strata, tumors 1.5-3.0 cm and 3.1-5.0 cm.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Performance status Eastern Cooperative Oncology Group (ECOG) < 2.
* Life expectancy (> 1 year).
* New diagnosis of a renal tumor (within past 3 months).
* Measurable, predominantly (> 80%) solid renal neoplasm between 1.5-5.0 cm.
* Lesion concerning for kidney cancer bases on a contrast-enhanced CT or magnetic resonance imaging (MRI).
* No definitive evidence of metastatic disease.
* Does not require urgent surgical treatment.
* Candidate for surgical, ablative, and surveillance approach.
* Willingness to obtain more information to aid decision-making.
* Understanding and willingness to provide consent.

Exclusion Criteria:

* Presence of multiple solid renal tumors.
* A prior needle biopsy of the mass resulting in histologic diagnosis.
* A prior diagnosis of kidney cancer.
* Presence of an active, untreated, non-renal malignancy.
* History of bleeding diathesis or recent bleeding episode.
* Prior surgery or radiation therapy to the kidney.
* Unwillingness to fill out questionnaires.

• Brian Shuch, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center