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OpenTrials
Completed

NCT Number: NCT03125629

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

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.

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Key information

Conditions

Cancer Diagnosis Diagnostic Imaging Diagnostic Techniques and Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

F-18 FDG

Drug

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

Ga-68-DOTA-TATE

Drug

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

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

Device

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

Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan

Device

Scan using a NOVEL GE PET/MRI scanner.

Primary outcomes

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

    Time frame: 4 hours

    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.

Secondary outcomes

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

    Time frame: estimated average of 2 hours

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Comparison of PET/CT vs. PET/MRI

Important dates

Study start
2014
Primary completion
2016
Study completion
2020
First posted
Apr 24, 2017
Registry last updated
Apr 9, 2021

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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