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CompletedNCT02378337pet-ctUpdated Nov 28, 2017

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

An observational study in Malignant Neoplasm of Breast, Hodgkin Disease and Non-Hodgkin Lymphoma, Follicular (Nodular), sponsored by Hospital Sao Rafael. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Hospital Sao Rafael · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
335
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Malignant Neoplasm of Breast
  • Hodgkin Disease
  • Non-Hodgkin Lymphoma, Follicular (Nodular)
  • Malignant Neoplasm of Bronchus and Lung
  • Malignant Neoplasm of Colon
  • Secondary Neoplasm Malignant and Unspecified Lymph Nodes
  • Malignant Melanoma of the Skin
  • Malignant Neoplasm of Small Intestine
03

In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 335 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Hospital Sao Rafael is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant women;
  • Patients who have lesions in the liver metabolically active whether primary or metastatic;
  • Patients with movement difficulties.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
335 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • OtherImage 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.

06

What researchers measure

Primary outcomes

  1. Correlation of body weight with the variation coefficient (image noise).

    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.

    Time frame: 360 seconds

Secondary outcomes

  1. Correlation of dose-regimen with the variation coefficient (image noise).

    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.

    Time frame: 360 seconds

  2. Correlation of acquisition protocol time with the variation coefficient (image noise).

    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.

    Time frame: 360 seconds

07

Study locations

1 site
  • Hospital Sao Rafael
    Salvador, Estado de Bahia, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02378337
Lead sponsor
Hospital Sao Rafael
Responsible party
Milena Botelho Pereira Soares (PhD, Hospital Sao Rafael) — Principal investigator
First posted
Mar 4, 2015
Start date
Sep 2014
Primary completion
Aug 2015
Completion
Mar 2016
Last update
Nov 28, 2017

Study contacts

Milena BP Soares, PhD
principal investigator · Hospital São Rafael
Vinicius O Menezes, BSc
study chair · Hospital São Rafael
Marcos AD Machado, BSc
study chair · Hospital São Rafael
Cleiton C Queiroz, BSc
study chair · Hospital São Rafael
Mauro Namias, MSc
study chair · Fundacion Centro Diagnostico Nuclear

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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