A Comparison of Static and Dynamic PET/CT (HYPOTHESIS Generation Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D-WB PET/CT.
- Who it may be relevant to
- Registry conditions: Oncology, Infections, Inflammation. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparison of Static and Dynamic PET/CT in Patients With Malignancies, Infections and Inflammatory Diseases (HYPOTHESIS Generation Study)
Overview
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
- 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.
Primary outcome measures
- 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]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus
Publications
- Pedersen MA, Dias AH, Hjorthaug K, Gormsen LC, Fledelius J, Johnsson AL, Borgquist S, Tramm T, Munk OL, Vendelbo MH. Increased lesion detectability in patients with locally advanced breast cancer-A pilot study using dynamic whole-body [18F]FDG PET/CT. EJNMMI Res. 2024 Mar 25;14(1):31. doi: 10.1186/s13550-024-01096-4. PMID 38528239
Identifiers
NCT: NCT05110443 · HYPOTHESIS