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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Cancer Diagnosis; Diagnostic Imaging; Diagnostic Techniques and Procedures

Treatments: Device: Positron Emission Tomography / Computed Tomography (PET/CT) Scan; Device: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan; Drug: Ga-68-DOTA-TATE; Drug: F-18 FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT03125629

IRB-27398

NCI-2017-00364 (Registry Identifier)

VARIMG0004 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 4 patient groups

18F-FDG PET/CT Scan

Experimental group

Description:

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

Treatment:

Drug: F-18 FDG

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

18F-FDG PET/MRI Scan

Experimental group

Description:

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

Treatment:

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

Drug: F-18 FDG

68Ga-DOTA-TATE PET/CT Scan

Experimental group

Description:

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

Treatment:

Drug: Ga-68-DOTA-TATE

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

68Ga-DOTA-TATE PET/MRI Scan

Experimental group

Description:

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

Treatment:

Drug: Ga-68-DOTA-TATE

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