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

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ClinicalTrials.gov Identifier: NCT02378337
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Milena Botelho Pereira Soares, 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.

Condition or disease Intervention/treatment
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 Other: Image quantify

Study Type : Observational
Actual Enrollment : 335 participants
Observational Model: Cohort
Time Perspective: Other
Actual Study Start Date : September 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : March 2016


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378337


Locations
Brazil
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

Responsible Party: Milena Botelho Pereira Soares, PhD, Hospital Sao Rafael
ClinicalTrials.gov Identifier: NCT02378337     History of Changes
Other Study ID Numbers: 27558714.4.0000.0048
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Neoplasms
Lymphoma, Non-Hodgkin
Melanoma
Hodgkin Disease
Lymphoma, Follicular
Breast Neoplasms
Bronchial Neoplasms
Colonic Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Breast Diseases
Skin Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bronchial Diseases
Respiratory Tract Diseases