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A Comparison of Static and Dynamic PET/CT (HYPOTHESIS Generation Study)

A Comparison of Static and Dynamic PET/CT in Patients With Malignancies, Infections and Inflammatory Diseases (HYPOTHESIS Generation Study)

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05110443
Enrollment
500
Registered
2021-11-08
Start date
2020-02-18
Completion date
2026-08-31
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Inflammation, Oncology

Keywords

PET/CT, FDG, Dynamic Whole-Body

Brief summary

The general purpose of this initial study is to evaluate whether parametric PET/CT improves diagnosis and treatment monitoring in select diseases. The specific aim of the HYPOTHESIS GENERATION study is: 1\. To obtain and compare parametric as well as traditional static PET/CT images and determine the number of lesions identified on each type of scan.

Detailed description

The hypothesis generating study will include a wide range of patients scheduled for PET/CT as part of either pre-therapy staging or treatment response. Most scans will be performed with FDG, with indications for PET/CT including hematological, urogenital, thoracic and gynecological malignancies as well as patients with suspected infections and inflammation. We will also include patients referred for PET/CT using other radiotracers, such as tumour markers (68Ga-DOTATOC, 18F-FDOPA, 68Ga-PSMA, 18F-PSMA). Instead of the usual procedure of having the injection of the radiotracer in the waiting room and having to wait 60 minutes before being moved to the scanner room for imaging, the study participants will be injected with the radiotracer already laying on the scanner bed and the scan will commence immediately. Therefore, in this study the patients are still only being scanned once, but we are gathering PET information in a different way.

Interventions

OTHERD-WB PET/CT

Instead of the usual procedure of having the injection of the radiotracer in the waiting room and having to wait 60 minutes before being moved to the scanner room for imaging, the study participants will be injected with the radiotracer already laying on the scanner bed and the scan will commence immediately. Therefore, in this study the patients are still only being scanned once, but we are gathering PET information in a different way.

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients with a planned clinical standard PET/CT as part of pre-therapeutic staging, response assessment scanning or evaluation of infection/inflammation. * Good performance status, which permits patients to lay still in the scanner for ca. 70 min.

Exclusion criteria

* Age \< 18 or \> 85 years * Patients that can not tolerate a PET scan (f.ex: claustrophobia).

Design outcomes

Primary

MeasureTime frameDescription
Obtaining a database of parametric and traditional static PET/CT images for comparison of visual and semiquantitative evaluationthrough study completion, average 1 yearWe will perform a correlation of the image derived from parametric PET/CT with those obtained from static PET/CT. This will allow us to evaluate if there are clinical advantages in regards to using parametric PET in clinical routine.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026