Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2018-12-07
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Health service research (MIBI SPECT/CT, questionnaire)
Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
Computed Tomography
Undergo SPECT/CT
Questionnaire Administration
Ancillary studies
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Technetium Tc-99m Sestamibi
Given IV
Interventions
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Computed Tomography
Undergo SPECT/CT
Questionnaire Administration
Ancillary studies
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Technetium Tc-99m Sestamibi
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brian Shuch
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2019-02711
Identifier Type: REGISTRY
Identifier Source: secondary_id
18-001817
Identifier Type: -
Identifier Source: org_study_id
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