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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06424873
Other study ID # 2023-02102
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source University Hospital, Geneva
Contact Valentina Garibotto, Pr
Phone +41223727252
Email valentina.garibotto@hcuge.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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].


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients clinically indicated for whole-body PET evaluation. 2. Patient must agree to lie still in the camera. 3. Patient must be able to comply with study procedures. 4. Patient must be able to provide informed consent. Exclusion Criteria: 1. Patients < 18 years of age. 2. Pregnant women are excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
PET/CT with FDG or FES
The study consists of an additional 50 minutes of imaging during the radiotracer's uptake phase prior to their clinical scan (standard of care).

Locations

Country Name City State
Switzerland Geneva University Hospitals Geneva

Sponsors (1)

Lead Sponsor Collaborator
Valentina Garibotto

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Standard SUV measurement metric 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 Image quality This will be assessed by clinical PET/CT readers, on a 5 point scale. through study completion , an average of 2 years
Secondary Certainty in diagnosis of FDG-avid processes This will be assessed by clinical PET/CT readers, on a 5 point scale. through study completion , an average of 2 years
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