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Enrolling by Invitation

NCT Number: NCT05110443

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

D-WB PET/CT

Other

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.

Primary outcomes

  1. Obtaining a database of parametric and traditional static PET/CT images for comparison of visual and semiquantitative evaluation

    Time frame: through study completion, average 1 year

    We 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.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2021
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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