NCT03996850

SPECT/CT for the Characterization of Renal Masses

SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 102 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Kidney Neoplasm
• Renal Mass

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo SPECT/CT
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Single Photon Emission Computed Tomography	Undergo SPECT/CT
RADIATION	Technetium Tc-99m Sestamibi	Given IV

Timeline

• Start date: 2018-12-07
• Primary completion: 2025-03-03
• Completion: 2027-12-31
• First posted: 2019-06-25
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States