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

Not Applicable

• Conditions: Infections; Oncology; Inflammation
• Interventions: Other: D-WB PET/CT

• Registration Number: NCT05110443
• Lead Sponsor: Aarhus University Hospital

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.

Study Timeline

• Study Start: 2020-02-18
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main arm	D-WB PET/CT	Patients will perform a D-WB PET/CT scan as a substitute for their clinical PET.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark