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

Sponsor
Hospital Sao Rafael (Other)
Overall Status
Completed
CT.gov ID
NCT02378337
Collaborator
(none)
335
1
18
18.6

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
335 participants
Observational Model:
Cohort
Time Perspective:
Other
Actual Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Sao Rafael Salvador Bahia Brazil

Sponsors and Collaborators

  • Hospital Sao Rafael

Investigators

  • Principal Investigator: Milena BP Soares, PhD, Hospital São Rafael
  • Study Chair: Vinicius O Menezes, BSc, Hospital São Rafael
  • Study Chair: Marcos AD Machado, BSc, Hospital São Rafael
  • Study Chair: Cleiton C Queiroz, BSc, Hospital São Rafael
  • Study Chair: Mauro Namias, MSc, Fundacion Centro Diagnostico Nuclear

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Milena Botelho Pereira Soares, PhD, Hospital Sao Rafael
ClinicalTrials.gov Identifier:
NCT02378337
Other Study ID Numbers:
  • 27558714.4.0000.0048
First Posted:
Mar 4, 2015
Last Update Posted:
Nov 28, 2017
Last Verified:
Nov 1, 2017

Study Results

No Results Posted as of Nov 28, 2017