SPECT/CT for the Characterization of Renal Masses

Kidney Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03996850
• Other study ID #: 18-001817
• Secondary ID: NCI-2019-02711
• Status: Recruiting
• Start date: December 7, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Neoplasm
• Kidney Neoplasms
• Renal Mass

Intervention

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

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient management decision	Assessed with post-test, physician counseling.	6 months
Secondary	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