Cancer DiagnosisPhase 2NCT03125629

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

A Phase 2 study testing F-18 FDG, Ga-68-DOTA-TATE and Positron Emission Tomography / Computed Tomography (PET/CT) Scan in people with Cancer Diagnosis and Diagnostic Techniques and Procedures, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer Diagnosis, Diagnostic Techniques and Procedures, Diagnostic Imaging
What is being tested?: F-18 FDG, Ga-68-DOTA-TATE and Positron Emission Tomography / Computed Tomography (PET/CT) Scan
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: 27 May 2014to 5 Feb 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Pregnant or nursing
Metallic implants
Impaired renal function

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University, School of Medicine
Palo Alto, California, 94304

Other trials in United States

About this study

Official title: Comparison of PET/CT vs. PET/MRI

Read the detailed description

PRIMARY OBJECTIVES:

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: Cancer Diagnosis, Diagnostic Techniques and Procedures, Diagnostic Imaging
Being tested: F-18 FDG, Ga-68-DOTA-TATE, Positron Emission Tomography / Computed Tomography (PET/CT) Scan, Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03125629
Study group	Role	What they receive
18F-FDG PET/CT Scan	Experimental	Participants will undergo a PET/CT scan with radiolabel 18F-FDG. Receives: Drug: F-18 FDG; Device: 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. Receives: Drug: F-18 FDG; Device: 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. Receives: Drug: Ga-68-DOTA-TATE; Device: 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. Receives: Drug: Ga-68-DOTA-TATE; Device: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 hours

Secondary outcomes (1)

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.
Measured: estimated average of 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 20145 Feb 2020

First posted24 Apr 2017
Study start27 May 2014
Primary completion30 Nov 2016
Study completion5 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cancer DiagnosisStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: All participants receive both scans.
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03125629
Sponsor's protocol ID: IRB-27398
Other IDs: NCI-2017-00364, VARIMG0004
Status last verified: Apr 2021
First submitted: 24 Mar 2017
Last updated: 9 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of PET/CT vs. PET/MRI
ClinicalTrials.gov ID: NCT03125629
Acronym / sponsor ID: IRB-27398
Conditions: Cancer Diagnosis, Diagnostic Techniques and Procedures, Diagnostic Imaging
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 27 May 2014 (actual)
Primary completion: 30 Nov 2016 (actual)
Study completion: 5 Feb 2020 (actual)
First posted: 24 Apr 2017 (actual)
Results: Posted 8 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To evaluate if PET/CT and PET/MRI scanners provide equivalent results for evaluation of cancer patients.

OUTLINE:

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: All participants receive both scans.

Arm	Type	Receives
18F-FDG PET/CT Scan	Experimental	Drug: F-18 FDG, Device: Positron Emission Tomography / Computed Tomography (PET/CT) ScanParticipants will undergo a PET/CT scan with radiolabel 18F-FDG.
18F-FDG PET/MRI Scan	Experimental	Drug: F-18 FDG, Device: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) ScanParticipants will undergo a PET/MRI scan with radiolabel 18F-FDG.
68Ga-DOTA-TATE PET/CT Scan	Experimental	Drug: Ga-68-DOTA-TATE, Device: Positron Emission Tomography / Computed Tomography (PET/CT) ScanParticipants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.
68Ga-DOTA-TATE PET/MRI Scan	Experimental	Drug: Ga-68-DOTA-TATE, Device: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) ScanParticipants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

Pregnant or nursing
Metallic implants
Impaired renal function

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

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.

1 secondary outcome

PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer
Time frame: estimated average of 2 hours

Results and safety

Results posted to the registry on 8 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Participant Flow	53	50

Primary outcome: Absolute Accuracy of SUV Max of PET/CT vs PET/MRI

Time frame: 4 hours. Mean (Standard Deviation). Unit: ratio

Measure	18F-FDG PET/CT Scan n = 44	18F-FDG PET/MRI Scan n = 42	68Ga-DOTA-TATE PET/CT Scan n = 6	68Ga-DOTA-TATE PET/MRI Scan n = 6
Aortic arch	1.78 (0.42)	1.08 (0.38)	0.54 (0.22)	0.51 (0.19)
Gluteal muscle	0.79 (0.20)	0.94 (0.28)	0.42 (0.19)	0.47 (0.25)
Gluteal fat	0.27 (0.10)	0.26 (0.09)	0.14 (0.06)	0.24 (0.07)
Cerebellum	8.56 (2.64)	7.79 (2.49)	0.22 (0.09)	0.12 (0.12)
Parotid Gland	1.71 (0.68)	1.76 (0.77)	1.28 (0.60)	1.06 (0.26)
Lung	0.57 (0.21)	0.36 (0.15)	0.31 (0.05)	0.26 (0.20)
Liver	2.72 (0.66)	2.21 (0.59)	9.47 (7.15)	10.86 (7.60)
Spleen	2.18 (0.82)	2.03 (0.97)	13.07 (3.75)	15.74 (3.16)

Population analysed: Not all scans at all body locations could be completed.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
18F-FDG PET/CT Scan	0 of 44 (0%)	0 of 44 (0%)	0 of 44
18F-FDG PET/MRI Scan	0 of 42 (0%)	0 of 42 (0%)	0 of 42
68Ga-DOTA-TATE PET/CT Scan	0 of 6 (0%)	0 of 6 (0%)	0 of 6
68Ga-DOTA-TATE PET/MRI Scan	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrei Iagaru principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Accuracy of SUV Max of PET/CT vs PET/MRI (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03125629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.