Kidney NeoplasmNCT03996850
SPECT/CT for the Characterization of Renal Masses
An observational study of Kidney Neoplasm and Renal Mass, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasm, Renal Mass
- What is being tested?
- Computed Tomography, Questionnaire Administration and Single Photon Emission Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with new diagnosis of a renal tumor (within past 3 months)
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the impact of technetium Tc-99m sestamibi (MIBI) SPECT/CT on patient management decisions.
SECONDARY OBJECTIVES:
- 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.
- 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:
- 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
- Kidney Neoplasm, Renal Mass
- Being tested
- Computed Tomography, Questionnaire Administration, Single Photon Emission Computed Tomography, Technetium Tc-99m Sestamibi
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo SPECT/CT
Questionnaire AdministrationOther
Ancillary studies
Single Photon Emission Computed TomographyProcedure or surgery
Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT
Undergo SPECT/CT
Technetium Tc-99m SestamibiRadiation
Also called Cardiolite, Miraluma, Tc 99m Sestamibi, Tc-99m MIBI
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Health service research (MIBI SPECT/CT, questionnaire) | Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT. Receives: Procedure: Computed Tomography; Other: Questionnaire Administration; Procedure: Single Photon Emission Computed Tomography; Radiation: Technetium Tc-99m Sestamibi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient management decision
Assessed with post-test, physician counseling.
Measured: 6 months
Secondary outcomes (1)
Decision making based on tumor size
Could be differentially impacted in two strata, tumors 1.5-3.0 cm and 3.1-5.0 cm.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start7 Dec 2018
- Primary completion3 Mar 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Shuch, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996850
- Sponsor's protocol ID
- 18-001817
- Other IDs
- NCI-2019-02711
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2019
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making
- ClinicalTrials.gov ID
- NCT03996850
- Acronym / sponsor ID
- 18-001817
- Conditions
- Kidney Neoplasm, Renal Mass
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the impact of technetium Tc-99m sestamibi (MIBI) SPECT/CT on patient management decisions.
SECONDARY OBJECTIVES:
- 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.
- 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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health service research (MIBI SPECT/CT, questionnaire) | – | Procedure: Computed Tomography, Other: Questionnaire Administration, Procedure: Single Photon Emission Computed Tomography, Radiation: Technetium Tc-99m SestamibiPatients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with new diagnosis of a renal tumor (within past 3 months)
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo SPECT/CT | Procedure or surgery | Health service research (MIBI SPECT/CT, questionnaire) |
| Questionnaire AdministrationAncillary studies | Other | Health service research (MIBI SPECT/CT, questionnaire) |
| Single Photon Emission Computed TomographyAlso: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECTUndergo SPECT/CT | Procedure or surgery | Health service research (MIBI SPECT/CT, questionnaire) |
| Technetium Tc-99m SestamibiAlso: Cardiolite, Miraluma, Tc 99m Sestamibi, Tc-99m MIBIGiven IV | Radiation | Health service research (MIBI SPECT/CT, questionnaire) |
Primary outcome
Change in patient management decision
Time frame: 6 months
Assessed with post-test, physician counseling.
1 secondary outcome
Decision making based on tumor size
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Shuch principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Neoplasm and Renal Mass, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient management decision (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.