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

NCT05110443 | Enrolling By Invitation

• 1 other identifier: HYPOTHESIS
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oncology; Infections; Inflammation

Keywords

PET/CT; FDG; Dynamic Whole-Body

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Main arm

OTHER

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

Other: D-WB PET/CT

Interventions

D-WB PET/CT 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.

Main arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Neoplasms; Infections; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 8, 2021
• Study Start: February 18, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)