SPECT/CT for the Characterization of Renal Masses
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVES:
- To determine the impact of technetium Tc-99m sestamibi (MIBI) SPECT/CT on patient management decisions.
SECONDARY OBJECTIVES:
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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.
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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.
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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.
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To compare the specificity of MIBI SPECT/CT with conventional cross-sectional imaging in predicting an oncocytic renal mass.
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To assess the correlation between MIBI SPECT/CT outcomes to final treatment decisions.
EXPLORATORY OBJECTIVES:
- 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Health service research (MIBI SPECT/CT, questionnaire) Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT. |
Procedure: Computed Tomography
Undergo SPECT/CT
Other Names:
Other: Questionnaire Administration
Ancillary studies
Procedure: Single Photon Emission Computed Tomography
Undergo SPECT/CT
Other Names:
Radiation: Technetium Tc-99m Sestamibi
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in patient management decision [6 months]
Assessed with post-test, physician counseling.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Performance status Eastern Cooperative Oncology Group (ECOG) < 2.
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Life expectancy (> 1 year).
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New diagnosis of a renal tumor (within past 3 months).
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Measurable, predominantly (> 80%) solid renal neoplasm between 1.5-5.0 cm.
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Lesion concerning for kidney cancer bases on a contrast-enhanced CT or magnetic resonance imaging (MRI).
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No definitive evidence of metastatic disease.
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Does not require urgent surgical treatment.
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Candidate for surgical, ablative, and surveillance approach.
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Willingness to obtain more information to aid decision-making.
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Understanding and willingness to provide consent.
Exclusion Criteria:
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Presence of multiple solid renal tumors.
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A prior needle biopsy of the mass resulting in histologic diagnosis.
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A prior diagnosis of kidney cancer.
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Presence of an active, untreated, non-renal malignancy.
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History of bleeding diathesis or recent bleeding episode.
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Prior surgery or radiation therapy to the kidney.
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Unwillingness to fill out questionnaires.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- Jonsson Comprehensive Cancer Center
Investigators
- Principal Investigator: Brian Shuch, UCLA / Jonsson Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-001817
- NCI-2019-02711