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

Hodgkin Disease Clinical Trial

— pet-ct  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378337
• Other study ID #: 27558714.4.0000.0048
• Status: Completed
• Phase: N/A
• First received: February 13, 2015
• Last updated: November 27, 2017
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2017
• Source: Hospital Sao Rafael
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: March 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Sao Rafael	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Rafael

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	360 seconds
Secondary	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.	360 seconds