Dynamic Whole-body PET/CT Imaging in Clinical Oncology

Not Applicable

Recruiting

• Conditions: Cancer
• Interventions: Radiation: PET/CT with FDG or FES

• Registration Number: NCT06424873
• Lead Sponsor: Valentina Garibotto

Brief 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 .

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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 Timeline

• Study First Submitted: 2023-11-09
• Study Start: 2024-04-01
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-16
• Last Update Submitted: 2024-05-16
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One arm study	PET/CT with FDG or FES	Additionnal images during PET/CT

Primary Outcome Measures

Name	Time	Method
Standard SUV measurement metric	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.

Secondary Outcome Measures

Name	Time	Method
Image quality	through study completion , an average of 2 years	This will be assessed by clinical PET/CT readers, on a 5 point scale.
Certainty in diagnosis of FDG-avid processes	through study completion , an average of 2 years	This will be assessed by clinical PET/CT readers, on a 5 point scale.

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland