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Active, Not Recruiting

NCT Number: NCT03996850

SPECT/CT for the Characterization of Renal Masses

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computed Tomography

Procedure

Undergo SPECT/CT

Other names: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Questionnaire Administration

Other

Ancillary studies

Single Photon Emission Computed Tomography

Procedure

Undergo SPECT/CT

Other names: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon

Technetium Tc-99m Sestamibi

Radiation

Given IV

Other names: Cardiolite, Miraluma, Tc 99m Sestamibi, Tc-99m MIBI, Tc99m Sestamibi

Primary outcomes

  1. Change in patient management decision

    Time frame: 6 months

    Assessed with post-test, physician counseling.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2027
First posted
Jun 25, 2019
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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