Clinical trial NCT03996850: SPECT/CT for the Characterization of Renal Masses
Official title: SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Neoplasm
Renal Mass
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with new diagnosis of a renal tumor (within past 3 months)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in patient management decision
timeFrame: 6 months
Secondary outcomes:
measure: Decision making based on tumor size
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Brian Shuch
role: PRINCIPAL_INVESTIGATOR
References: