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

NCT02378337 | Completed

• 1 other identifier: 27558714.4.0000.0048
• Study Type: observational
• Target: 335
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  360 seconds

Secondary Outcomes (2)

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

  360 seconds

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

  360 seconds

Study Arms (2)

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

Image quantify OTHER

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; Retrospective development cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Sao Rafael: lead

Study Sites (1)

Hospital Sao Rafael

Salvador, Estado de Bahia, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Hodgkin Disease; Lymphoma, Non-Hodgkin; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Milena BP Soares, PhD

  Hospital São Rafael

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: March 4, 2015
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: March 1, 2016
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

BR (1)