Defining PET / CT Protocols With Optimized F18-FDG (Fluorodeoxyglucose) Dose, Focusing on Reduced Radiation Dose and Improved Image Quality

Completed

• Conditions: Malignant Neoplasm of Bronchus and Lung; Secondary Neoplasm Malignant and Unspecified Lymph Nodes; Malignant Neoplasm of Small Intestine; Non-Hodgkin Lymphoma, Follicular (Nodular); Malignant Neoplasm of Colon; Malignant Neoplasm of Breast; Hodgkin Disease; Malignant Melanoma of the Skin
• Interventions: Other: Image quantify

• Registration Number: NCT02378337
• Lead Sponsor: Hospital Sao Rafael

Brief Summary

Identify the best combination of predictive variables that influence ionizing radiation dose and improved image quality through analysis and quantification of PET-CT images in simulators and patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-04
• Primary Completion: 2015-08
• Study Completion: 2016-03
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• Healthy volunteers;
• Both genders;
• Age over 18 years;
• Clinical indication for PET-CT scan.

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Exclusion Criteria

• Pregnant women;
• Patients who have lesions in the liver metabolically active whether primary or metastatic;
• Patients with movement difficulties.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective development cohort	Image quantify	A total of 85 18F-FDG-PET adult studies were gathered over a 3-month period and retrospectively evaluated.
Prospective validation cohort	Image quantify	To verify the application of methodology in clinical routine, we conducted a second phase of the study prospectively in 250 subjects (phase 2) using inclusion and exclusion criteria of the retrospective study (phase 1).

Primary Outcome Measures

Name	Time	Method
Correlation of body weight with the variation coefficient (image noise).	360 seconds	The image noise will be measured by VOI (Volume Of Interest) in the images. The units of measure will be kilograms (kg) for body weight, and percentage for the variation coefficient.

Secondary Outcome Measures

Name	Time	Method
Correlation of dose-regimen with the variation coefficient (image noise).	360 seconds	The dose-regimen will be calculated based on radiation dose and body surface. The image noise will be measured by VOI (Volume Of Interest) in the images. The units of measure will be MegaBecquerel per kilogram (MBq/kg) for dose-regimen, and percentage for the variation coefficient.
Correlation of acquisition protocol time with the variation coefficient (image noise).	360 seconds	Images will be acquired every 30 seconds until a maximum of 360 seconds. The image noise will be measured by VOI (Volume Of Interest) in the images. The units of measure will be seconds for the acquisition time, and percentage for the variation coefficient.

Trial Locations

Locations (1)

Hospital Sao Rafael; 🇧🇷 Salvador, Bahia, Brazil