Kidney Neoplasm, Renal Mass
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo SPECT/CT
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURESingle Photon Emission Computed Tomography
Undergo SPECT/CT
RADIATIONTechnetium Tc-99m Sestamibi
Given IV
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient management decision | 6 months | Assessed with post-test, physician counseling. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian Shuch
UCLA / Jonsson Comprehensive Cancer Center
Outcome results
None listed