SPECT/CT for the Characterization of Renal Masses

Recruiting

• Conditions: Kidney Neoplasm; Renal Mass
• Interventions: Procedure: Computed Tomography; Other: Questionnaire Administration; Procedure: Single Photon Emission Computed Tomography; Radiation: Technetium Tc-99m Sestamibi

• Registration Number: NCT03996850
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 2018-12-07
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health service research (MIBI SPECT/CT, questionnaire)	Computed Tomography	Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
Health service research (MIBI SPECT/CT, questionnaire)	Questionnaire Administration	Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
Health service research (MIBI SPECT/CT, questionnaire)	Single Photon Emission Computed Tomography	Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
Health service research (MIBI SPECT/CT, questionnaire)	Technetium Tc-99m Sestamibi	Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.

Primary Outcome Measures

Name	Time	Method
Change in patient management decision	6 months	Assessed with post-test, physician counseling.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States