HealthyNCT04110743

EXPLORER PET/CT in Healthy Volunteers

A study testing EXPLORER PET/CT in people with Healthy, run by University of California, Davis 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

The objective of this pilot study is to collect preliminary data using total body scans on a new, first of its kind, FDA 510k-cleared positron emission tomography/computed tomography (PET/CT) scanner, called EXPLORER. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: EXPLORER PET/CT
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 19 Jun 2019to 6 Feb 2020
Phase: Interventional
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Men and women, 18 years of age or older
Willing and able to fast for at least 6 hours before and for the duration of the scan
Willing and able to lay motionless in a supine position for 60 and 20 minutes at separate timepoints.
Willing and able to give informed consent

Who cannot join

No Primary Care Physician
Body weight >240 kg
Allergy to iodine contrast (only for subjects enrolled in Arm 3)
Creatinine levels > 1.5 mg/dL or estimated glomerular filtration rate (eGFR) < 60 ml/minute (only for subjects enrolled in Arm 3)
Recent (1 month) contrast enhanced CT
Any known concomitant acute infection (including upper respiratory infection, genitourinary infections, etc.

Show all 17Show fewer

History of metastatic or newly (last 5 years) diagnosed locally invasive cancer.
Chemotherapy in the last 5 years
Radiation therapy in the last 3 years
Major surgery within the last 6 months.
Pregnancy or breast-feeding
Diabetes
Fasting blood glucose level > 160 mg/dL before administration of FDG
Prisoners
The standard MRI contraindications apply, including but not limited to:
Having a pacemaker or other implanted electronic device. Metal foreign bodies, aneurysm clips, heart valve prosthesis, vascular stents, cochlear implants, embolization coils, gunshot wounds with retained bullet fragments, penile implant, IUCD.
Claustrophobia

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, Davis
Sacramento, California, 95817

Other trials in United States

About this study

Official title: EXPLORER PET/CT: A Pilot Evaluation in Healthy Volunteers

Conditions: Healthy
Being tested: EXPLORER PET/CT

What participants receive

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

EXPLORER PET/CTDevice
Intervention: PET/CT using different protocols

Study groups in NCT04110743
Study group	Role	What they receive
delayed imaging acquisition	Other	10 mCi of 18F fluorodeoxyglucose (FDG) will be injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The IV line will be removed after dynamic acquisition. The dynamic scan will be preceded by ultra low-dose (1.298 mSv) CT scan to provide information for attenuation correction for the PET data. At 90 minutes, 3-, 6-, 9- and 12-hours, a static whole-body scan for 20 minutes will be acquired on EXPLORER. Prior to the 90-minute scan a low-dose CT (7.44 mSv) will be obtained both for anatomic localization and for attenuation correction purposes. Prior to each of the later time-points (3-, 6-, 9- and 12-hours), an ultra low-dose (1.298 mSv) CT scan will be acquired. This scan will be for attenuation correction purposes only. Following the 12-hour scan, the participant's study visit will be completed. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. Receives: Device: EXPLORER PET/CT
low FDG dose imaging	Other	0.5 mCi of 18F-FDG (1/20th of the standard dose) will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The dynamic scan will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction. The standard 20-minute EXPLORER scan obtained at 90 minutes will be obtained after a low dose CT (7.44 mSv) for attenuation and co-localization. The standard 20-minute EXPLORER scan obtained at 3 hours will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction only. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. Receives: Device: EXPLORER PET/CT
comparison PET images reconstructed using CT-based attenuation	Other	10 mCi of 18F-FDG will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. Prior to the dynamic scan, an ultra-low-dose CT scan (1.298 mSv) will be acquired for attenuation correction purposes only. At 90 mins, a low dose non contrast enhancement CT (7.44 mSv) will be acquired vertex to toes. Iodinated contrast (150 cc of iodine Omnipaque 350) will then be intravenously injected (through the same IV placed to inject FDG) at 3 ml/sec while the patient remains still on the scanner and a second low-dose CT will be acquired. Finally, a 20-minute PET acquisition will be performed. The IV line will be removed after completion of the study. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. Receives: Device: EXPLORER PET/CT

What is being measured

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

Standardized Uptake Value SUV(t)= C(t)/ID/BW; C(t) is Radioactivity Measured at the Time t, Decay Corrected to t=0 and Converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; W= Body Weight; SUV is Correct UM
To collect preliminary data regarding FDG biodistribution in the organs listed as a function of time of 12 hours. Time-activity curves will be created
Measured: approximatively 12 hours for Arm 1 only
Coefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)
To obtain preliminary data regarding low dose EXPLORER noise level
Measured: approximatively 6 hours for Arm 1 only
Standardized Uptake Value
To collect preliminary data about total body FDG perfusion and early biodistribution. Time-activity curves will be created
Measured: approximatively 90 minutes
Standardized Uptake Value SUV(t)= C(t)/(ID/BW); C(t) is Radioactivity Measured From at Time t, Decay Corrected to t=0-converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; BW= Body Weight; SUV is Correct UM
To obtain preliminary data to understand whether intravenous iodinated contrast agent produce a significant change in quantification of FDG uptake levels.
Time/activity curves will be generated.
Measured: approximatively 3 hours

Timeline

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

19 Jun 20196 Feb 2020

First posted1 Oct 2019
Study start19 Jun 2019
Primary completion6 Feb 2020
Study completion6 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 HealthyStudies of the same condition, open and under way.
More trials run by University of California, DavisThe 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 N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04110743
Sponsor's protocol ID: 1341792
Status last verified: Aug 2023
First submitted: 18 Sep 2019
Last updated: 21 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

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?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EXPLORER PET/CT: A Pilot Evaluation in Healthy Volunteers
ClinicalTrials.gov ID: NCT04110743
Acronym / sponsor ID: 1341792
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of California, DavisUniversity, hospital or other
Study start: 19 Jun 2019 (actual)
Primary completion: 6 Feb 2020 (actual)
Study completion: 6 Feb 2020 (actual)
First posted: 1 Oct 2019 (actual)
Results: Posted 21 Nov 2024

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
delayed imaging acquisition	Other	Device: EXPLORER PET/CT10 mCi of 18F fluorodeoxyglucose (FDG) will be injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The IV line will be removed after dynamic acquisition. The dynamic scan will be preceded by ultra low-dose (1.298 mSv) CT scan to provide information for attenuation correction for the PET data. At 90 minutes, 3-, 6-, 9- and 12-hours, a static whole-body scan for 20 minutes will be acquired on EXPLORER. Prior to the 90-minute scan a low-dose CT (7.44 mSv) will be obtained both for anatomic localization and for attenuation correction purposes. Prior to each of the later time-points (3-, 6-, 9- and 12-hours), an ultra low-dose (1.298 mSv) CT scan will be acquired. This scan will be for attenuation correction purposes only. Following the 12-hour scan, the participant's study visit will be completed. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation.
low FDG dose imaging	Other	Device: EXPLORER PET/CT0.5 mCi of 18F-FDG (1/20th of the standard dose) will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The dynamic scan will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction. The standard 20-minute EXPLORER scan obtained at 90 minutes will be obtained after a low dose CT (7.44 mSv) for attenuation and co-localization. The standard 20-minute EXPLORER scan obtained at 3 hours will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction only. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation.
comparison PET images reconstructed using CT-based attenuation	Other	Device: EXPLORER PET/CT10 mCi of 18F-FDG will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. Prior to the dynamic scan, an ultra-low-dose CT scan (1.298 mSv) will be acquired for attenuation correction purposes only. At 90 mins, a low dose non contrast enhancement CT (7.44 mSv) will be acquired vertex to toes. Iodinated contrast (150 cc of iodine Omnipaque 350) will then be intravenously injected (through the same IV placed to inject FDG) at 3 ml/sec while the patient remains still on the scanner and a second low-dose CT will be acquired. Finally, a 20-minute PET acquisition will be performed. The IV line will be removed after completion of the study. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men and women, 18 years of age or older
Willing and able to fast for at least 6 hours before and for the duration of the scan
Willing and able to lay motionless in a supine position for 60 and 20 minutes at separate timepoints.
Willing and able to give informed consent

Key exclusion criteria (17 listed)

No Primary Care Physician
Body weight >240 kg
Allergy to iodine contrast (only for subjects enrolled in Arm 3)
Creatinine levels > 1.5 mg/dL or estimated glomerular filtration rate (eGFR) < 60 ml/minute (only for subjects enrolled in Arm 3)
Recent (1 month) contrast enhanced CT

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
EXPLORER PET/CTIntervention: PET/CT using different protocols	Device	comparison PET images reconstructed using CT-based attenuation, delayed imaging acquisition, low FDG dose imaging

Primary outcome

Standardized Uptake Value SUV(t)= C(t)/ID/BW; C(t) is Radioactivity Measured at the Time t, Decay Corrected to t=0 and Converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; W= Body Weight; SUV is Correct UM
Time frame: approximatively 12 hours for Arm 1 only
To collect preliminary data regarding FDG biodistribution in the organs listed as a function of time of 12 hours. Time-activity curves will be created
Coefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)
Time frame: approximatively 6 hours for Arm 1 only
To obtain preliminary data regarding low dose EXPLORER noise level
Standardized Uptake Value
Time frame: approximatively 90 minutes
To collect preliminary data about total body FDG perfusion and early biodistribution. Time-activity curves will be created
Standardized Uptake Value SUV(t)= C(t)/(ID/BW); C(t) is Radioactivity Measured From at Time t, Decay Corrected to t=0-converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; BW= Body Weight; SUV is Correct UM
Time frame: approximatively 3 hours
To obtain preliminary data to understand whether intravenous iodinated contrast agent produce a significant change in quantification of FDG uptake levels. Time/activity curves will be generated.

Results and safety

Results posted to the registry on 21 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Delayed Imaging Acquisition	15	15
Low FDG Dose Imaging	15	15
Comparison PET Images Reconstructed Using CT-based Attenuation	0	0

Primary outcome: Standardized Uptake Value SUV(t)= C(t)/ID/BW; C(t) is Radioactivity Measured at the Time t, Decay Corrected to t=0 and Converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; W= Body Weight; SUV is Correct UM

Time frame: approximatively 12 hours for Arm 1 only. Mean (Standard Deviation). Unit: SUV

Measure	Delayed Imaging Acquisition n = 15
Aorta	0.83 (0.47)
Lungs	0.48 (0.44)
Liver	1.68 (0.51)
Spleen	2.01 (0.49)
Kidneys	1.91 (0.83)
Bone Marrow	3.44 (0.85)
Skeletal Muscles	1.23 (0.44)
Subcutaneous Fat	0.25 (0.21)

Primary outcome: Coefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)

Time frame: approximatively 6 hours for Arm 1 only. Mean (Standard Deviation). Unit: coefficient

Measure	Delayed Imaging Acquisition n = 15
Aorta	60.5 (14.8)
Lungs	140.1 (8.1)
Liver	32.2 (9.0)
Spleen	31.4 (9.3)
Kidneys	64.4 (18.4)
Bone Marrow	40.8 (11.8)
Skeletal Muscles	53.0 (18.8)
Subcutaneous Fat	88.6 (24.8)

Primary outcome: Standardized Uptake Value

Time frame: approximatively 90 minutes. Mean (Standard Deviation). Unit: SUV

Measure	Delayed Imaging Acquisition n = 15	Arm 2 n = 15
Aorta	1.75 (0.34)	0.88 (0.17)
Lungs	0.62 (0.37)	0.32 (0.06)
Liver	2.49 (0.44)	1.02 (0.19)
Spleen	2.15 (0.40)	0.83 (0.15)
Kidneys	3.65 (1.85)	1.45 (0.23)
Bone Marrow	2.51 (0.44)	0.73 (0.15)
Skeletal Muscles	0.70 (0.19)	0.37 (0.06)
Subcutaneous Fat	0.19 (0.05)	0.19 (0.04)

Primary outcome: Standardized Uptake Value SUV(t)= C(t)/(ID/BW); C(t) is Radioactivity Measured From at Time t, Decay Corrected to t=0-converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; BW= Body Weight; SUV is Correct UM

Time frame: approximatively 3 hours. Mean (Standard Deviation). Unit: SUV

Measure	Delayed Imaging Acquisition n = 15	Arm 2 n = 15
Aorta	1.18 (0.30)	0.39 (0.08)
Lungs	0.52 (0.53)	0.15 (0.04)
Liver	2.11 (0.42)	0.50 (0.10)
Spleen	2.09 (0.41)	0.43 (0.08)
Kidneys	3.30 (1.34)	0.66 (0.12)
Bone Marrow	2.92 (0.56)	0.44 (0.09)
Skeletal Muscles	0.82 (0.21)	0.21 (0.04)
Subcutaneous Fat	0.16 (0.05)	0.07 (0.02)

Adverse events

Time frame: AEs were collected during the study protocol activity of the one appointment for approximately 3 hours at which time the subject was off study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delayed Imaging Acquisition	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Low FDG Dose Imaging	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Comparison PET Images Reconstructed Using CT-based Attenuation	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Logistical limitations did not allow us to enroll in Arm 3. It was originally expected that a CT with contrast could be completed on the EXPLORER scanner. It was learned during study activation that it could not. an additional limitation was finding research staff to complete follow up data collection delaying in reporting of the results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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.

Lorenzo Nardo, MD principal investigator

University of California, Davis

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

Questions about this trial

What is this clinical trial studying?

A study testing EXPLORER PET/CT in people with Healthy, run by University of California, Davis at 1 site in United States.

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 17 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 21 Nov 2024. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2024). 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?

Standardized Uptake Value SUV(t)= C(t)/ID/BW; C(t) is Radioactivity Measured at the Time t, Decay Corrected to t=0 and Converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; W= Body Weight; SUV is Correct UM (time frame: approximatively 12 hours for Arm 1 only). The study lists 4 primary outcomes in all. 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 NCT04110743.

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 21 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.