Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
Study NCT ID:
NCT03996850
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2019-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SPECT/CT for the Characterization of Renal Masses
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2019-02711 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |