SPECT/CT for the Characterization of Renal Masses

N/AActive Not RecruitingNCT03996850

Jonsson Comprehensive Cancer Center102 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

102

Conditions

Kidney Neoplasm Renal Mass

Interventions

Computed TomographyPROCEDURE

Undergo SPECT/CT

Questionnaire AdministrationOTHER

Ancillary studies

Single Photon Emission Computed TomographyPROCEDURE

Undergo SPECT/CT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Change in patient management decision

Assessed with post-test, physician counseling.

Time frame: 6 months

Secondary Outcomes

Decision making based on tumor size

Could be differentially impacted in two strata, tumors 1.5-3.0 cm and 3.1-5.0 cm.

Time frame: 6 months

Data from ClinicalTrials.gov

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