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

Aarhus University Hospital

Status: Invitation-only

Conditions: Inflammation; Oncology; Infections

Treatments: Other: D-WB PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05110443

HYPOTHESIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Main arm

Other group

Description:

Patients will perform a D-WB PET/CT scan as a substitute for their clinical PET.

Treatment:

Other: D-WB PET/CT