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

Sponsor
Aarhus University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05110443
Collaborator
(none)
500
1
1
30.4
16.5

Study Details

Study Description

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.
Condition or Disease Intervention/Treatment Phase
  • Other: D-WB PET/CT
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Comparison of Static and Dynamic PET/CT in Patients With Malignancies, Infections and Inflammatory Diseases (HYPOTHESIS Generation Study)
Actual Study Start Date :
Feb 18, 2020
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Main arm

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

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.

Outcome Measures

Primary Outcome Measures

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

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aarhus University Hospital Aarhus Denmark

Sponsors and Collaborators

  • Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
André H. Dias, Principal Investigator, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT05110443
Other Study ID Numbers:
  • HYPOTHESIS
First Posted:
Nov 8, 2021
Last Update Posted:
Feb 22, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by André H. Dias, Principal Investigator, Aarhus University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 22, 2022