NCT03125629

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 8, 2021

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

2.5 years

First QC Date

March 24, 2017

Results QC Date

November 6, 2020

Last Update Submit

April 8, 2021

Conditions

Cancer DiagnosisDiagnostic Techniques and ProceduresDiagnostic Imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    estimated average of 2 hours

Study Arms (4)

18F-FDG PET/CT Scan

EXPERIMENTAL

Participants will undergo a PET/CT scan with radiolabel 18F-FDG.

Drug: F-18 FDGDevice: Positron Emission Tomography / Computed Tomography (PET/CT) Scan

18F-FDG PET/MRI Scan

EXPERIMENTAL

Participants will undergo a PET/MRI scan with radiolabel 18F-FDG.

Drug: F-18 FDGDevice: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan

68Ga-DOTA-TATE PET/CT Scan

EXPERIMENTAL

Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.

Drug: Ga-68-DOTA-TATEDevice: Positron Emission Tomography / Computed Tomography (PET/CT) Scan

68Ga-DOTA-TATE PET/MRI Scan

EXPERIMENTAL

Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.

Drug: Ga-68-DOTA-TATEDevice: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan

Interventions

F-18 FDGDRUG

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

18F-FDG PET/CT Scan18F-FDG PET/MRI Scan
Ga-68-DOTA-TATEDRUG

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

68Ga-DOTA-TATE PET/CT Scan68Ga-DOTA-TATE PET/MRI Scan
Positron Emission Tomography / Computed Tomography (PET/CT) ScanDEVICE

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

18F-FDG PET/CT Scan68Ga-DOTA-TATE PET/CT Scan
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) ScanDEVICE

Scan using a NOVEL GE PET/MRI scanner.

18F-FDG PET/MRI Scan68Ga-DOTA-TATE PET/MRI Scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer diagnosis
  • Capable of complying with study procedures
  • Able to remain still for duration of imaging procedure (approximately 90 minutes total)
  • Written informed consent

You may not qualify if:

  • Pregnant or nursing
  • Metallic implants
  • Impaired renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

gallium Ga 68 dotatatePositron-Emission TomographyTomography, X-Ray ComputedPositron Emission Tomography Computed TomographyRadionuclide ImagingMagnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyTomographyDiagnostic Techniques, RadioisotopeRadiographic Image EnhancementRadiographyTomography, X-RayMultimodal Imaging

Results Point of Contact

Title
Andrei Iagaru
Organization
Stanford University
aiagaru@stanford.edu
650-725-4711

Study Officials

  • Andrei Iagaru

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: All participants receive both scans.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiology

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 24, 2017

Study Start

May 27, 2014

Primary Completion

November 30, 2016

Study Completion

February 5, 2020

Last Updated

April 9, 2021

Results First Posted

April 8, 2021

Record last verified: 2021-04

Locations

US(1)