SPECT/CT for the Characterization of Renal Masses

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA / Jonsson Comprehensive Cancer Center
      • Contact: Brian Shuch; Phone Number: 310-794-7700; Email: BShuch@mednet.ucla.edu
      • Principal Investigator: Brian Shuch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with new diagnosis of a renal tumor (within past 3 months)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Health service research (MIBI SPECT/CT, questionnaire); Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient management decision	Assessed with post-test, physician counseling.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Investigators: Principal Investigator: Brian Shuch, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium Tc 99m Sestamibi
• Other Study ID Numbers: 18-001817; NCI-2019-02711 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No