## Protocol Section
### Identification Module
**NCT ID:** NCT06424873

**Acronym:** Dynamic PET/CT

**Brief Title:** Dynamic Whole-body PET/CT Imaging in Clinical Oncology

**Official Title:** Dynamic Whole-body PET/CT Imaging in Clinical Oncology

#### Organization Study ID Info
**ID:** 2023-02102
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Geneva
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-09
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Valentina Garibotto

#### Responsible Party

**Investigator Affiliation:** University Hospital, Geneva

**Investigator Full Name:** Valentina Garibotto

**Investigator Title:** Head of the Division of Nuclear Medicine and Molecular imaging

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 .

The main question\[s\] it aims to answer are:

* \[question 1\]
* \[question 2\] Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\].

**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.

### Conditions Module

**Conditions:**

- Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** PET/CT

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Additionnal images during PET/CT

**Intervention Names:**

- Radiation: PET/CT with FDG or FES

**Label:** One arm study

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- One arm study

**Description:** The study consists of an additional 50 minutes of imaging during the radiotracer's uptake phase prior to their clinical scan (standard of care).

**Name:** PET/CT with FDG or FES

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Standard SUV measurement metric

**Time Frame:** through study completion , an average of 2 years

#### Secondary Outcomes

**Description:** This will be assessed by clinical PET/CT readers, on a 5 point scale.

**Measure:** Image quality

**Time Frame:** through study completion , an average of 2 years

**Description:** This will be assessed by clinical PET/CT readers, on a 5 point scale.

**Measure:** Certainty in diagnosis of FDG-avid processes

**Time Frame:** through study completion , an average of 2 years

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** valentina.garibotto@hcuge.ch

**Name:** Valentina Garibotto, Pr

**Phone:** +41223727252

**Role:** CONTACT

**Contact 2:**

**Email:** IsminiCharis.Mainta@hcuge.ch

**Name:** Ismini Mainta, Dr

**Phone:** +41795534454

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Geneva

**Contacts:**

***Contact 1:***

- **Email:** valentina.garibotto@hcuge.ch

- **Name:** Valentina Garibotto

- **Role:** CONTACT

**Country:** Switzerland

**Facility:** Geneva University Hospitals

**Status:** RECRUITING

**Zip:** 1205

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
