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NCT04110743

EXPLORER PET/CT in Healthy Volunteers

Completed NA Results posted Last updated 21 November 2024
What this trial tests

NA trial testing EXPLORER PET/CT in Healthy in 30 participants. Completed in 6 February 2020.

Timeline
19 June 2019
Primary endpoint
6 February 2020
6 February 2020

Quick facts

Lead sponsorUniversity of California, Davis
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment30
Start date19 June 2019
Primary completion6 February 2020
Estimated completion6 February 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Davis

Who can join

18 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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

Aorta
GroupValue95% CI
Delayed Imaging Acquisition0.83± 0.47
Lungs
GroupValue95% CI
Delayed Imaging Acquisition0.48± 0.44
Liver
GroupValue95% CI
Delayed Imaging Acquisition1.68± 0.51
Spleen
GroupValue95% CI
Delayed Imaging Acquisition2.01± 0.49
Kidneys
GroupValue95% CI
Delayed Imaging Acquisition1.91± 0.83
Bone Marrow
GroupValue95% CI
Delayed Imaging Acquisition3.44± 0.85
Skeletal Muscles
GroupValue95% CI
Delayed Imaging Acquisition1.23± 0.44
Subcutaneous Fat
GroupValue95% CI
Delayed Imaging Acquisition0.25± 0.21
Coefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value) Primary · approximatively 6 hours for Arm 1 only

To obtain preliminary data regarding low dose EXPLORER noise level

Aorta
GroupValue95% CI
Delayed Imaging Acquisition60.5± 14.8
Lungs
GroupValue95% CI
Delayed Imaging Acquisition140.1± 8.1
Liver
GroupValue95% CI
Delayed Imaging Acquisition32.2± 9.0
Spleen
GroupValue95% CI
Delayed Imaging Acquisition31.4± 9.3
Kidneys
GroupValue95% CI
Delayed Imaging Acquisition64.4± 18.4
Bone Marrow
GroupValue95% CI
Delayed Imaging Acquisition40.8± 11.8
Skeletal Muscles
GroupValue95% CI
Delayed Imaging Acquisition53.0± 18.8
Subcutaneous Fat
GroupValue95% CI
Delayed Imaging Acquisition88.6± 24.8
Standardized Uptake Value Primary · approximatively 90 minutes

To collect preliminary data about total body FDG perfusion and early biodistribution. Time-activity curves will be created

Aorta
GroupValue95% CI
Delayed Imaging Acquisition1.75± 0.34
Arm 20.88± 0.17
Lungs
GroupValue95% CI
Delayed Imaging Acquisition0.62± 0.37
Arm 20.32± 0.06
Liver
GroupValue95% CI
Delayed Imaging Acquisition2.49± 0.44
Arm 21.02± 0.19
Spleen
GroupValue95% CI
Delayed Imaging Acquisition2.15± 0.40
Arm 20.83± 0.15
Kidneys
GroupValue95% CI
Delayed Imaging Acquisition3.65± 1.85
Arm 21.45± 0.23
Bone Marrow
GroupValue95% CI
Delayed Imaging Acquisition2.51± 0.44
Arm 20.73± 0.15
Skeletal Muscles
GroupValue95% CI
Delayed Imaging Acquisition0.70± 0.19
Arm 20.37± 0.06
Subcutaneous Fat
GroupValue95% CI
Delayed Imaging Acquisition0.19± 0.05
Arm 20.19± 0.04
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 Primary · 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.

Aorta
GroupValue95% CI
Delayed Imaging Acquisition1.18± 0.30
Arm 20.39± 0.08
Lungs
GroupValue95% CI
Delayed Imaging Acquisition0.52± 0.53
Arm 20.15± 0.04
Liver
GroupValue95% CI
Delayed Imaging Acquisition2.11± 0.42
Arm 20.50± 0.10
Spleen
GroupValue95% CI
Delayed Imaging Acquisition2.09± 0.41
Arm 20.43± 0.08
Kidneys
GroupValue95% CI
Delayed Imaging Acquisition3.30± 1.34
Arm 20.66± 0.12
Bone Marrow
GroupValue95% CI
Delayed Imaging Acquisition2.92± 0.56
Arm 20.44± 0.09
Skeletal Muscles
GroupValue95% CI
Delayed Imaging Acquisition0.82± 0.21
Arm 20.21± 0.04
Subcutaneous Fat
GroupValue95% CI
Delayed Imaging Acquisition0.16± 0.05
Arm 20.07± 0.02

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Long Axial Field-of-View PET/CT Could Answer Unmet Needs in Gynecological Cancers.
    Triumbari EKA, Rufini V, Mingels C, Rominger A, et al · · 2023 · cited 8× · PMID 37173874 · DOI 10.3390/cancers15092407

Verify or expand the search:

Other trials of EXPLORER PET/CT

Trials testing the same drug.

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other University of California, Davis trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04110743.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing