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

NCT ID: NCT02378337

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospective development cohort

A total of 85 18F-FDG-PET adult studies were gathered over a 3-month period and retrospectively evaluated.

Image quantify

Intervention Type 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

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).

Image quantify

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Sao Rafael

OTHER

Sponsor Role lead

Responsible Party

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Milena Botelho Pereira Soares

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Milena BP Soares, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital São Rafael

Vinicius O Menezes, BSc

Role: STUDY_CHAIR

Hospital São Rafael

Marcos AD Machado, BSc

Role: STUDY_CHAIR

Hospital São Rafael

Cleiton C Queiroz, BSc

Role: STUDY_CHAIR

Hospital São Rafael

Mauro Namias, MSc

Role: STUDY_CHAIR

Fundacion Centro Diagnostico Nuclear

Locations

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Hospital Sao Rafael

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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27558714.4.0000.0048

Identifier Type: -

Identifier Source: org_study_id