Thinking of joining a study?

Register your interest

Become a volunteer?

NCT03996850 | RECRUITING | Kidney Neoplasm

SPECT/CT for the Characterization of Renal Masses
Sponsor:

Jonsson Comprehensive Cancer Center

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.

Condition or disease

Kidney Neoplasm

Renal Mass

Intervention/treatment

Computed Tomography

Questionnaire Administration

Single Photon Emission Computed Tomography

Technetium Tc-99m Sestamibi

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making
Actual Study Start Date : 2018-12-07
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
SPECT/CT for the Characterization of Renal Masses

Location Details

NCT03996850

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095