- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06424873
Dynamic Whole-body PET/CT Imaging in Clinical Oncology (Dynamic PET/CT)
The goal of this clinical trial is to to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times in patient with oncologic pathology .
The main question[s] it aims to answer are:
- [question 1]
- [question 2] Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items].
Study Overview
Detailed Description
Whole body hybrid PET/CT imaging, making use of the standardized uptake value (SUV), is well established in clinical setting for diagnosis and staging, treatment response monitoring and radiation therapy treatment planning of a wide range of oncologic malignancies. However, the SUV metric derived from static PET data does not capture the dynamics of the PET probe biodistribution in the body.
The present work proposes to fill in this notable gap: namely to merge whole-body and dynamic PET/CT imaging, to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times. Our proposed approach has the potential to significantly enhance diagnostic, prognostic and treatment response monitoring capabilities of PET/CT and to fundamentally alter routine clinical practice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Valentina Garibotto, Pr
- Phone Number: +41223727252
- Email: valentina.garibotto@hcuge.ch
Study Contact Backup
- Name: Ismini Mainta, Dr
- Phone Number: +41795534454
- Email: IsminiCharis.Mainta@hcuge.ch
Study Locations
-
-
-
Geneva, Switzerland, 1205
- Recruiting
- Geneva University Hospitals
-
Contact:
- Valentina Garibotto
- Email: valentina.garibotto@hcuge.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients clinically indicated for whole-body PET evaluation.
- Patient must agree to lie still in the camera.
- Patient must be able to comply with study procedures.
- Patient must be able to provide informed consent.
Exclusion Criteria:
- Patients < 18 years of age.
- Pregnant women are excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: One arm study
Additionnal images during PET/CT
|
The study consists of an additional 50 minutes of imaging during the radiotracer's uptake phase prior to their clinical scan (standard of care).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standard SUV measurement metric
Time Frame: through study completion , an average of 2 years
|
The standard SUV measurement metric will be compared with the measured influx rate Ki as obtained from dynamic PET/CT imaging for FDG-avid processes.
We expect a correlation coefficient of at least 0.8.
|
through study completion , an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Image quality
Time Frame: through study completion , an average of 2 years
|
This will be assessed by clinical PET/CT readers, on a 5 point scale.
|
through study completion , an average of 2 years
|
Certainty in diagnosis of FDG-avid processes
Time Frame: through study completion , an average of 2 years
|
This will be assessed by clinical PET/CT readers, on a 5 point scale.
|
through study completion , an average of 2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023-02102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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