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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03125629
Other study ID # IRB-27398
Secondary ID NCI-2017-00364VA
Status Completed
Phase Phase 2
First received
Last updated
Start date May 27, 2014
Est. completion date February 5, 2020

Study information

Verified date April 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date February 5, 2020
Est. primary completion date November 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
F-18 FDG
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Ga-68-DOTA-TATE
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Device:
Positron Emission Tomography / Computed Tomography (PET/CT) Scan
Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan
Scan using a NOVEL GE PET/MRI scanner.

Locations

Country Name City State
United States Stanford University, School of Medicine Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 hours
Secondary 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.
estimated average of 2 hours
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