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SPECT/CT for the Characterization of Renal Masses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996850
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : April 12, 2023
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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
Kidney Neoplasm Renal Mass Procedure: Computed Tomography Other: Questionnaire Administration Procedure: Single Photon Emission Computed Tomography Radiation: Technetium Tc-99m Sestamibi

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Groups and Cohorts
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Group/Cohort 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:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Other: Questionnaire Administration
Ancillary studies

Procedure: Single Photon Emission Computed Tomography
Undergo SPECT/CT
Other Names:
  • Medical Imaging, Single Photon Emission Computed Tomography
  • Single Photon Emission Tomography
  • single-photon emission computed tomography
  • SPECT
  • SPECT imaging
  • SPECT SCAN
  • SPET
  • tomography, emission computed, single photon
  • Tomography, Emission-Computed, Single-Photon

Radiation: Technetium Tc-99m Sestamibi
Given IV
Other Names:
  • Cardiolite
  • Miraluma
  • Tc 99m Sestamibi
  • Tc-99m MIBI
  • Tc99m Sestamibi


Outcome Measures
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Primary Outcome Measures :
  1. Change in patient management decision [ Time Frame: 6 months ]
    Assessed with post-test, physician counseling.


Secondary Outcome Measures :
  1. 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
Tissue

Eligibility Criteria
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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
Study Population
Patients with new diagnosis of a renal tumor (within past 3 months)
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Brian Shuch UCLA / Jonsson Comprehensive Cancer Center
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03996850    
Other Study ID Numbers: 18-001817
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

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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
Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action