SPECT/CT for the Characterization of Renal Masses
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|ClinicalTrials.gov Identifier: NCT03996850|
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : April 12, 2023
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|Condition or disease||Intervention/treatment|
|Kidney Neoplasm Renal Mass||Procedure: Computed Tomography Other: Questionnaire Administration Procedure: Single Photon Emission Computed Tomography Radiation: Technetium Tc-99m Sestamibi|
I. To determine the impact of technetium Tc-99m sestamibi (MIBI) SPECT/CT on patient management decisions.
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.
I. Evaluate the mitochondria content in tumors that had positive MIBI SPECT/CT findings.
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|
|Estimated Enrollment :||100 participants|
|Official Title:||SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making|
|Actual Study Start Date :||December 7, 2018|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
Health service research (MIBI SPECT/CT, questionnaire)
Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
Procedure: Computed Tomography
Other: Questionnaire Administration
Procedure: Single Photon Emission Computed Tomography
Radiation: Technetium Tc-99m Sestamibi
- Change in patient management decision [ Time Frame: 6 months ]Assessed with post-test, physician counseling.
- Decision making based on tumor size [ Time Frame: 6 months ]Could be differentially impacted in two strata, tumors 1.5-3.0 cm and 3.1-5.0 cm.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996850
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Brian Shuch 310-794-7700 BShuch@mednet.ucla.edu|
|Principal Investigator: Brian Shuch|
|Principal Investigator:||Brian Shuch||UCLA / Jonsson Comprehensive Cancer Center|
|Responsible Party:||Jonsson Comprehensive Cancer Center|
|Other Study ID Numbers:||
NCI-2019-02711 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
|First Posted:||June 25, 2019 Key Record Dates|
|Last Update Posted:||April 12, 2023|
|Last Verified:||July 2022|
|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|
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Technetium Tc 99m Sestamibi
Molecular Mechanisms of Pharmacological Action