Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals

Stanford University53 enrolled

Overview

This clinical trial studies how well positron emission tomography (PET)/computed tomography (CT) works compared to PET/magnetic resonance imaging (MRI) in evaluating patients with cancer. PET/CT and PET/MRI may determine which scanner is best for the patient's type of cancer and other types of cancers.

PRIMARY OBJECTIVES: I. To evaluate if PET/CT and PET/MRI scanners provide equivalent results for evaluation of cancer patients. OUTLINE: Patients receive standard of care 18F-fludeoxyglucose (FDG) or Ga68-DOTA-TATE intravenously (IV). Within 45-60 minutes, patients then undergo PET/CT imaging immediately followed by PET/MRI. Each participant is to receive 18-FDG or 68Ga-DOTA-TATE only, no participant was to receive both radiotracers.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cancer Diagnosis Diagnostic Techniques and Procedures Diagnostic Imaging

Interventions

F-18 FDGDRUG

Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging

Ga-68-DOTA-TATEDRUG

Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging

Positron Emission Tomography / Computed Tomography (PET/CT) ScanDEVICE

Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

INCLUSION CRITERIA * Cancer diagnosis * Capable of complying with study procedures * Able to remain still for duration of imaging procedure (approximately 90 minutes total) * Written informed consent EXCLUSION CRITERIA * Pregnant or nursing * Metallic implants * Impaired renal function

Locations (1)

Stanford University, School of Medicine

Palo Alto, California, United States

Outcomes

Primary Outcomes

Absolute Accuracy of SUV Max of PET/CT vs PET/MRI

Standardized uptake value max (SUVmax) is a measurement of the maximum radiopharmaceutical uptake value within the region of interest (ROI). SUVmax is calculated as the ratio of activity concentration:injected dose/body weight. The outcome is reported as the mean SUVmax with standard deviation (SD), reported for 8 specific organs or bodily locations.

Time frame: 4 hours

Secondary Outcomes

PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer

Standardized uptake value max (SUVmax) is a measurement of the maximum radiopharmaceutical uptake within the region of interest (ROI). Relative accuracy of a particular radiotracer in a particular tissue is determined by expressing the absolute accuracy (obtained in the primary outcome measure) in terms of percent difference between SUVmax values obtained from PET/CT and PET/MR. Percentage difference is expressed as the difference of the means in SUVmax for the PET/CT and PET/MRI scan procedures for the particular radiotracer, divided by the mean between the values for the 2 scan procedures. The closer the percent difference is to 0%, the better the agreement between the two scanners. The outcome is expressed as the percentage difference, a number without dispersion.

Time frame: estimated average of 2 hours

Data from ClinicalTrials.gov

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