A Comparison of Static and Dynamic PET/CT (HYPOTHESIS Generation Study)
Primary Purpose
Oncology, Infections, Inflammation
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
D-WB PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Oncology focused on measuring PET/CT, FDG, Dynamic Whole-Body
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).
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Main arm
Arm Description
Patients will perform a D-WB PET/CT scan as a substitute for their clinical PET.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05110443
First Posted
October 13, 2021
Last Updated
February 21, 2022
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05110443
Brief Title
A Comparison of Static and Dynamic PET/CT (HYPOTHESIS Generation Study)
Official Title
A Comparison of Static and Dynamic PET/CT in Patients With Malignancies, Infections and Inflammatory Diseases (HYPOTHESIS Generation Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology, Infections, Inflammation
Keywords
PET/CT, FDG, Dynamic Whole-Body
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Main arm
Arm Type
Other
Arm Description
Patients will perform a D-WB PET/CT scan as a substitute for their clinical PET.
Intervention Type
Other
Intervention Name(s)
D-WB PET/CT
Intervention Description
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 Measure Information:
Title
Obtaining a database of parametric and traditional static PET/CT images for comparison of visual and semiquantitative evaluation
Description
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.
Time Frame
through study completion, average 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
According to local rules and GDRP it is not possible for study data to leave the facility.
Learn more about this trial
A Comparison of Static and Dynamic PET/CT (HYPOTHESIS Generation Study)
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