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SPECT/CT for the Characterization of Renal Masses
| 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 |
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 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, 2021 |
| Estimated Study Completion Date : | December 2022 |
| 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:
Other: Questionnaire Administration Ancillary studies
Procedure: Single Photon Emission Computed Tomography Undergo SPECT/CT
Other Names:
Radiation: Technetium Tc-99m Sestamibi Given IV
Other Names:
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- 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
| 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 |
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.
| 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 |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | June 21, 2019 | ||||||
| First Posted Date | June 25, 2019 | ||||||
| Last Update Posted Date | July 23, 2020 | ||||||
| Actual Study Start Date | December 7, 2018 | ||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
Change in patient management decision [ Time Frame: 6 months ] Assessed with post-test, physician counseling.
|
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
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.
|
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | SPECT/CT for the Characterization of Renal Masses | ||||||
| Official Title | SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making | ||||||
| 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. |
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| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Retention: Samples With DNA Description:
Tissue
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| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Patients with new diagnosis of a renal tumor (within past 3 months) | ||||||
| Condition |
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| Intervention |
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| Study Groups/Cohorts | Health service research (MIBI SPECT/CT, questionnaire)
Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
Interventions:
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
100 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | December 2022 | ||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | |||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03996850 | ||||||
| Other Study ID Numbers | 18-001817 NCI-2019-02711 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 18-001817 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center ) |
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| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Jonsson Comprehensive Cancer Center | ||||||
| Study Sponsor | Jonsson Comprehensive Cancer Center | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Jonsson Comprehensive Cancer Center | ||||||
| Verification Date | May 2020 | ||||||
