## Protocol Section
### Identification Module
**NCT ID:** NCT04660279

**Acronym:** VALIDATE

**Brief Title:** Dynamic FDG PET/CT: Optimization and Validation of Data Acquisition

**Official Title:** Dynamic Wholebody FDG PET/CT - Next Generational Functional Imaging: Optimization and Validation of Data Acquisition

#### Organization Study ID Info
**ID:** AarhusUH
#### Organization
**Class:** OTHER
**Full Name:** Aarhus University Hospital
### Status Module
#### Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-22

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2020-01-01

**Type:** ACTUAL

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2020-12-09
**Type:** ACTUAL
**Study First Submit Date:** 2020-08-19
**Study First Submit QC Date:** 2020-12-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Aarhus University Hospital

#### Responsible Party

**Investigator Affiliation:** Aarhus University Hospital

**Investigator Full Name:** André H. Dias

**Investigator Title:** Staff specialist, PhD Student

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Quantification of the metabolic rate of glucose from Dynamic Whole-Body PET examinations requires measurements of the time course of the radioactivity concentrations in arterial blood by blood sampling, and in the tissue of interest by dynamic PET. Invasive arterial blood sampling cannot be part of a standard examination, and therefore the blood samples need to be replaced by activity concentrations derived from the PET images, usually from small volumes in the descending aorta or left ventricle.

Newly developed scanner software (Siemens) allows automated CT-based identification of blood pool regions and extraction of an image-derived blood input function from the corresponding PET data.

However, this automated method needs validation, as it could be prone to systematic errors caused by limited spatial resolution, patient movement, and image reconstruction. We will use invasively measured arterial blood samples as a reference for validation of methods to extract non-invasive PET image-derived input functions and quantify any systematic errors that could propagate to the resulting parametric images.

### Conditions Module

**Conditions:**

- Positron-Emission Tomography

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** D-WB PET/CT scans + arterial blood sampling.

**Intervention Names:**

- Diagnostic Test: Dynamic Whole-Body parametric PET/CT

**Label:** Validate

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Validate

**Description:** Dynamic whole-body PET/CT imaging protocol

**Name:** Dynamic Whole-Body parametric PET/CT

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** We will perform a correlation of the image derived input function and the input function obtained from blood sampling. This will allow us to confirm that the information obtained by the equipment is accurate enough and can be trusted.

**Measure:** Validation of current parametric reconstruction protocol

**Time Frame:** through study completion, an average of 1 year

**Description:** After we have validated the image derived input function we will use the data we sampled to construct a "normal population" input function that can be applied to the current protocol. This way we will be able to skip the acquisition on the camera of the input function and be able to only scan the patients at a later period, therefor shortening the acquisition protocol to something more manageable in daily clinic.

**Measure:** Time reduction of current parametric reconstruction protocol

**Time Frame:** through study completion, an average of 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with a planned clinical standard PET/CT as part of pre-therapeutic staging, response assessment scanning.
* Good performance status, which will allow us to obtain informed consent to draw the required arterial blood samples during the examination, and which will permit patients to lay still in the scanner for at least 70 min.

Exclusion Criteria:

* • Age \< 18 or \> 85 years

  * Patients that can not tolerate a PET scan (f.ex: claustrophobia).

**Healthy Volunteers:** True

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aarhus

**Country:** Denmark

**Facility:** Aarhus University Hospital

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
