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

November 27, 2017 updated by: Milena Botelho Pereira Soares, Hospital Sao Rafael
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

335

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil
        • Hospital Sao Rafael

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Will be observed all patients who perform PET / CT examinations, independent of clinical indication, in nuclear medicine at Hospital Sao Rafael. Those who show interest in participating in the study, will be provided free and informed consent form (ICF) for your appreciation. This evaluation will serve for analysis and quantification of PET-CT images.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective development cohort
A total of 85 18F-FDG-PET adult studies were gathered over a 3-month period and retrospectively evaluated.
Other: Image quantify
Will be observed all patients who perform PET / CT examinations, independent of clinical indication, in nuclear medicine at Hospital Sao Rafael. Those who show interest in participating in the study, will be provided free and informed consent form (ICF) for your appreciation. This evaluation will serve for analysis and quantification of PET-CT images.
Prospective validation cohort
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).
Other: Image quantify
Will be observed all patients who perform PET / CT examinations, independent of clinical indication, in nuclear medicine at Hospital Sao Rafael. Those who show interest in participating in the study, will be provided free and informed consent form (ICF) for your appreciation. This evaluation will serve for analysis and quantification of PET-CT images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of body weight with the variation coefficient (image noise).
Time Frame: 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.
360 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of dose-regimen with the variation coefficient (image noise).
Time Frame: 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.
360 seconds
Correlation of acquisition protocol time with the variation coefficient (image noise).
Time Frame: 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.
360 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sao Rafael

Investigators

  • Study Chair: Vinicius O Menezes, BSc, Hospital Sao Rafael
  • Study Chair: Marcos AD Machado, BSc, Hospital Sao Rafael
  • Study Chair: Cleiton C Queiroz, BSc, Hospital Sao Rafael
  • Study Chair: Mauro Namias, MSc, Fundacion Centro Diagnostico Nuclear

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 13, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27558714.4.0000.0048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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