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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05110443
• Other study ID #: HYPOTHESIS
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 18, 2020
• Est. completion date: August 31, 2026

Study information

• Verified date: November 2023
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infections
• Inflammation
• Oncology

Intervention

Other:
• D-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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obtaining a database of parametric and traditional static PET/CT images for comparison of visual and semiquantitative evaluation	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.	through study completion, average 1 year