Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
Brian Shuch (ucla)

Description

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.

Official Title

SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making

Details

PRIMARY OBJECTIVES:

  1. To determine the impact of technetium Tc-99m sestamibi (MIBI) SPECT/CT on patient management decisions.

SECONDARY OBJECTIVES:

  1. 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.

  1. 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:

  1. 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.

Keywords

Kidney Neoplasm Renal Mass Kidney Neoplasms Technetium Tc 99m Sestamibi Computed Tomography Single Photon Emission Computed Tomography Technetium Tc-99m Sestamibi Health service research (MIBI SPECT/CT, questionnaire)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Location

  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Cancer

  • Brian Shuch (ucla)
    Associate Professor, Urology. Authored (or co-authored) 137 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT03996850
Study Type
Observational
Last Updated