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

NCT ID: NCT05110443

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-18

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Oncology Infections Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Main arm

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

Group Type OTHER

D-WB PET/CT

Intervention Type OTHER

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

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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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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André H. Dias

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 38528239 (View on PubMed)

Other Identifiers

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HYPOTHESIS

Identifier Type: -

Identifier Source: org_study_id

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