NCT04283552 is a NA clinical trial of Dynamic PET/CT Imaging in Dynamic PET/CT Imaging, sponsored by Washington University School of Medicine.

Who is sponsoring NCT04283552?

NCT04283552 is sponsored by Washington University School of Medicine.

What drugs are being tested in NCT04283552?

Interventions in NCT04283552: Dynamic PET/CT Imaging.

What condition does NCT04283552 study?

NCT04283552 studies Dynamic PET/CT Imaging.

Is NCT04283552 still recruiting?

NCT04283552 is currently terminated. Last updated 20 May 2024.

Are results published for NCT04283552?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-05-20 · How we verify

NCT04283552

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Gated and Non-Gated Dynamic PET/CT Imaging

Terminated NA Results posted Last updated 20 May 2024

What this trial tests

NA trial testing Dynamic PET/CT Imaging in Dynamic PET/CT Imaging in 80 participants. Terminated before completion.

Timeline

29 May 2020

Primary endpoint
10 April 2023

10 April 2023

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	80
Start date	29 May 2020
Primary completion	10 April 2023
Estimated completion	10 April 2023
Sites	1 location across United States

Drugs / interventions tested

Dynamic PET/CT Imaging

Conditions studied

Dynamic PET/CT Imaging — all drugs for Dynamic PET/CT Imaging →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Dynamic PET/CT Imaging. 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.

Feasibility of Rapid, Whole-body Dynamic PET Imaging as Measured by Number of Participants Who Successfully Completed the Study Imaging Component Primary · At time of scan (day 1)

-Successful completion of the study imaging component will be defined as: (1) patient remains on scanner for the full dynamic phase of PET imaging prior to the standard of care PET/CT and (2) automated scanner software is able to successfully generate valid parametric maps (requires at least three consecutive whole-body PET acquisitions without substantial motion between acquisitions).

Group	Value	95% CI
Dynamic PET Imaging	80

Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max Secondary · At the time of scan (Day 1)

Subjects underwent standard-of-care (SOC) PET acquisition with a respiratory-gating belt. Ungated (UG), belt-gating-derived optimal gate (BG-OG), EMCD utilizing belt gating (BG-EMCD), and EMCD utilizing data-driven gating (DDG-EMCD) images were reconstructed. Tracer-avid lesions in the lower chest or upper abdomen were segmented. Quantitative metrics were extracted.

Belt-gating optimal gate

Group	Value	95% CI
Dynamic PET Imaging	10.77	6.21 – 18.46

Elastic motion correction with blurring utilizing belt gating

Group	Value	95% CI
Dynamic PET Imaging	10.75	5.86 – 18.70

Elastic motion correction with blurring utilizing data-driven gating

Group	Value	95% CI
Dynamic PET Imaging	10.74	6.04 – 18.66

Ungated

Group	Value	95% CI
Dynamic PET Imaging	9.00	5.01 – 15.97

Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs) Secondary · At the time of scan (Day 1)

Belt-gating optimal gate

Group	Value	95% CI
Dynamic PET Imaging	6.31	3.97 – 12.08

Elastic motion correction with blurring utilizing belt gating

Group	Value	95% CI
Dynamic PET Imaging	9.14	5.59 – 15.87

Elastic motion correction with blurring utilizing data-driven gating

Group	Value	95% CI
Dynamic PET Imaging	8.89	5.50 – 17.05

Ungated

Group	Value	95% CI
Dynamic PET Imaging	7.89	4.99 – 15.17

Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate Secondary · At the time of scan (Day 1)

* Will be assessed by Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise.

Reader 1

Group	Value	95% CI
Dynamic PET Imaging Ungated	1.11	0 – 9
Dynamic PET/CT Belt-Gating Optimal Gate	0.14	0 – 9

Reader 2

Group	Value	95% CI
Dynamic PET Imaging Ungated	0.31	0 – 2
Dynamic PET/CT Belt-Gating Optimal Gate	0.14	0 – 2

Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Belt Gating Secondary · At the time of scan (Day 1)

Reader 1

Group	Value	95% CI
Dynamic PET Imaging Ungated	1.11	0 – 9
Dynamic PET/CT Elastic Motion Correction With Blurring Utilizing Belt Gating	1.28	0 – 9

Reader 2

Group	Value	95% CI
Dynamic PET Imaging Ungated	0.31	0 – 2
Dynamic PET/CT Elastic Motion Correction With Blurring Utilizing Belt Gating	0.50	0 – 2

Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Data-driven Gating Secondary · At the time of scan (Day 1)

Reader 1

Group	Value	95% CI
Dynamic PET Imaging Ungated	1.11	0 – 9
Dynamic PET/CT Elastic Motion Correction With Blurring Utilizing Data-Driven Gating	1.47	0 – 9

Reader 2

Group	Value	95% CI
Dynamic PET Imaging Ungated	0.31	0 – 2
Dynamic PET/CT Elastic Motion Correction With Blurring Utilizing Data-Driven Gating	0.50	0 – 2

Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Belt Gating Secondary · At the time of scan (Day 1)

* Will be assessed by Reader 1 and Reader 2 comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise.

Reader 1

Group	Value	95% CI
Dynamic PET Imaging Belt-gating Optimal Gate	0.14	0 – 1
Dynamic PET/CT Elastic Motion Correction With Blurring Utilizing Belt Gating	1.28	0 – 9

Reader 2

Group	Value	95% CI
Dynamic PET Imaging Belt-gating Optimal Gate	0.14	0 – 2
Dynamic PET/CT Elastic Motion Correction With Blurring Utilizing Belt Gating	0.50	0 – 2

Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Data-driven Gating Secondary · At the time of scan (Day 1)

* Will be assessed Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise.

Reader 1

Group	Value	95% CI
Dynamic PET Imaging Belt-gating Optimal Gate	0.14	0 – 1
Dynamic PET/CT Elastic Motion Correction With Blurring Utilizing Data-driven Gating	1.47	0 – 9

Reader 2

Group	Value	95% CI
Dynamic PET Imaging Belt-gating Optimal Gate	0.14	0 – 2
Dynamic PET/CT Elastic Motion Correction With Blurring Utilizing Data-driven Gating	0.50	0 – 2

Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Elastic Motion Correction With Blurring Utilizing Belt Gating and Elastic Motion Correction With Blurring Utilizing Data-driven Gating Secondary · At the time of scan (Day 1)

Reader 1

Group	Value	95% CI
Dynamic PET Imaging Elastic Motion Correction With Blurring Utilizing Belt Gating	1.28	0 – 9
Dynamic PET/CT Elastic Motion Correction With Blurring Utilizing Data-driven Gating	1.47	0 – 9

Reader 2

Group	Value	95% CI
Dynamic PET Imaging Elastic Motion Correction With Blurring Utilizing Belt Gating	0.50	0 – 2
Dynamic PET/CT Elastic Motion Correction With Blurring Utilizing Data-driven Gating	1.47	0 – 9

Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images Secondary · Day 1 and approximately 1 week later

* Standardized uptake value (SUV)-max, SUV-peak, Uptake time-corrected SUV (cSUV), Standardized uptake ratio (SUR), Uptake time-corrected standardized uptake ratio (cSUR), Patlak slope (PS)-max, and PS-peak were analyzed. * Test-retest repeatability of quantitative metrics based on the PS versus the SUV among lesions and normal organs on oncologic \[18F\]FDG-PET/CT. * Repeatability was assessed via mean test-retest percent changes \[T-RT %Δ\]

PS-max

Group	Value	95% CI
Dynamic PET Imaging	11	-32 – 54

PS-peak

Group	Value	95% CI
Dynamic PET Imaging	15	-30 – 59

SUV-max

Group	Value	95% CI
Dynamic PET Imaging	47	3 – 91

SUV-peak

Group	Value	95% CI
Dynamic PET Imaging	26	-22 – 75

cSUV-max

Group	Value	95% CI
Dynamic PET Imaging	-6	-53 – 41

cSUV-peak

Group	Value	95% CI
Dynamic PET Imaging	-27	-77 – 23

SUR-max

Group	Value	95% CI
Dynamic PET Imaging	81	48 – 114

SUR-peak

Group	Value	95% CI
Dynamic PET Imaging	63	23 – 102

Metabolic Rate of Images Secondary · At the time of scan (Day 1)

-Will help to determine the optimal post-injection time period for dynamic PET imaging for Early (35-50 min post-injection) and Late (75-90 min post-injection) Patlak slope (PS) analysis. Reader 1 and Reader 2 used a standard Likert score from 0-4 with 1 being the worst and 4 being the best. A higher score indicated the image was easier to read.

PS-Early Reader 1

Group	Value	95% CI
Dynamic PET Imaging	1.19	1 – 2

PS-Late Reader 1

Group	Value	95% CI
Dynamic PET Imaging	3.95	3 – 4

PS-Early Reader 2

Group	Value	95% CI
Dynamic PET Imaging	2.14	1 – 4

PS-Late Reader 2

Group	Value	95% CI
Dynamic PET Imaging	3.95	3 – 4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events and all-cause mortality were collected on the day of the PET/CT.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dynamic PET Imaging

Serious: 0/80 (0%)

Deaths: 0/80

Other adverse events (1 terms — click to expand)

Reaction	System	Dynamic PET Imaging
Erythema multiforme	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04283552 adverse events section.

Sponsor's own description

The goal of this study is to see how the images collected during the first hour compare with the routine images collected as part of the clinical scan.

Publications & conference data

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

Quantitative Assessments of Tumor Activity in a General Oncologic PET/CT Population: Which Metric Minimizes Tracer Uptake Time Dependence?
Ince S, Laforest R, Itani M, Prasad V, et al · · 2024 · cited 1× · PMID 39142828 · DOI 10.2967/jnumed.123.266469

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04283552 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 20 May 2024

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/NCT04283552.

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

NCT04283552

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other Washington University School of Medicine trials

Verify against primary sources