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

NCT ID: NCT03125629

Last Updated: 2021-04-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-27

Study Completion Date

2020-02-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer Diagnosis Diagnostic Techniques and Procedures Diagnostic Imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All participants receive both scans.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-FDG PET/CT Scan

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

Group Type EXPERIMENTAL

F-18 FDG

Intervention Type DRUG

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

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

Intervention Type DEVICE

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

18F-FDG PET/MRI Scan

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

Group Type EXPERIMENTAL

F-18 FDG

Intervention Type DRUG

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

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

Intervention Type DEVICE

Scan using a NOVEL GE PET/MRI scanner.

68Ga-DOTA-TATE PET/CT Scan

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

Group Type EXPERIMENTAL

Ga-68-DOTA-TATE

Intervention Type DRUG

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

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

Intervention Type DEVICE

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

68Ga-DOTA-TATE PET/MRI Scan

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

Group Type EXPERIMENTAL

Ga-68-DOTA-TATE

Intervention Type DRUG

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

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

Intervention Type DEVICE

Scan using a NOVEL GE PET/MRI scanner.

Interventions

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F-18 FDG

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

Intervention Type DRUG

Ga-68-DOTA-TATE

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

Intervention Type DRUG

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

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

Intervention Type DEVICE

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

Scan using a NOVEL GE PET/MRI scanner.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Andrei Iagaru

Associate Professor of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrei Iagaru

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University, School of Medicine

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NCI-2017-00364

Identifier Type: REGISTRY

Identifier Source: secondary_id

VARIMG0004

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-27398

Identifier Type: -

Identifier Source: org_study_id

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