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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Obtaining a database of parametric and traditional static PET/CT images for comparison of visual and semiquantitative evaluation [Срок оценки: through study completion, average 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Age < 18 or > 85 years
• Patients that can not tolerate a PET scan (f.ex: claustrophobia).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Дания · 1 центр

• Aarhus University Hospital — Aarhus

Публикации

• 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

Идентификаторы

NCT: NCT05110443 · HYPOTHESIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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