SPECT/CT for the Characterization of Renal Masses
2 other identifiers
observational
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2018
CompletedFirst Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedMarch 13, 2026
March 1, 2026
6.2 years
June 21, 2019
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in patient management decision
Assessed with post-test, physician counseling.
6 months
Secondary Outcomes (1)
Decision making based on tumor size
6 months
Study Arms (1)
Health service research (MIBI SPECT/CT, questionnaire)
Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
Interventions
Given IV
Undergo SPECT/CT
Ancillary studies
Undergo SPECT/CT
Eligibility Criteria
Patients with new diagnosis of a renal tumor (within past 3 months)
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Biospecimen
Tissue
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Shuch
UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
June 25, 2019
Study Start
December 7, 2018
Primary Completion
March 3, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
March 13, 2026
Record last verified: 2026-03