Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-02711 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health service research (MIBI SPECT/CT, questionnaire) | Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo SPECT/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient management decision | Assessed with post-test, physician counseling. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with new diagnosis of a renal tumor (within past 3 months)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Shuch | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
Not provided
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014965 | X-Rays |
| D017785 | Photons |
| D017256 | Technetium Tc 99m Sestamibi |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Tissue
| Questionnaire Administration | Other | Ancillary studies |
|
| Single Photon Emission Computed Tomography | Procedure | Undergo SPECT/CT |
|
|
| Technetium Tc-99m Sestamibi | Radiation | Given IV |
|
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D004601 | Elementary Particles |
| D008027 | Light |
| D055620 | Optical Phenomena |
| D011840 | Radiation, Nonionizing |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |