Malignant Neoplasm of Breastpet-ctNCT02378337
Defining PET / CT Protocols With Optimized F18-FDG (Fluorodeoxyglucose) Dose, Focusing on Reduced Radiation Dose and Improved Image Quality
An observational study of Malignant Neoplasm of Breast and Hodgkin Disease, run by Hospital Sao Rafael at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm of Breast, Hodgkin Disease, Non-Hodgkin Lymphoma, Follicular (Nodular)
- What is being tested?
- Image quantify
- How many people
- 335 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy volunteers;
- Both genders;
- Age over 18 years;
- Clinical indication for PET-CT scan.
Who cannot join
- Pregnant women;
- Patients who have lesions in the liver metabolically active whether primary or metastatic;
- Patients with movement difficulties.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Image quantify
- Medical subject headings
- Breast Neoplasms, Hodgkin Disease, Lymphoma, Non-Hodgkin, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image quantifyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective development cohort | A total of 85 18F-FDG-PET adult studies were gathered over a 3-month period and retrospectively evaluated. Receives: 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). Receives: Other: Image quantify |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 360 seconds
Secondary outcomes (2)
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.
Measured: 360 seconds
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.
Measured: 360 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Rafael
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milena Botelho Pereira Soares, Hospital Sao Rafael
- Investigators
- Milena BP Soares, PhD, Principal investigator, Hospital São RafaelVinicius O Menezes, BSc, Study chair, Hospital São RafaelMarcos AD Machado, BSc, Study chair, Hospital São RafaelCleiton C Queiroz, BSc, Study chair, Hospital São RafaelMauro Namias, MSc, Study chair, Fundacion Centro Diagnostico Nuclear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378337
- Sponsor's protocol ID
- 27558714.4.0000.0048
- Acronym
- pet-ct
- Status last verified
- Nov 2017
- First submitted
- 13 Feb 2015
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining PET / CT Protocols With Optimized F18-FDG (Fluorodeoxyglucose) Dose, Focusing on Reduced Radiation Dose and Improved Image Quality
- ClinicalTrials.gov ID
- NCT02378337
- Acronym / sponsor ID
- pet-ct / 27558714.4.0000.0048
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Hospital Sao RafaelUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective development cohort | – | Other: Image quantifyA total of 85 18F-FDG-PET adult studies were gathered over a 3-month period and retrospectively evaluated. |
| Prospective validation cohort | – | Other: Image quantifyTo 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Healthy volunteers;
- Both genders;
- Age over 18 years;
- Clinical indication for PET-CT scan.
Key exclusion criteria (3 listed)
- Pregnant women;
- Patients who have lesions in the liver metabolically active whether primary or metastatic;
- Patients with movement difficulties.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image quantifyWill 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. | Other | Prospective validation cohort, Retrospective development cohort |
Primary outcome
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.
2 secondary outcomes
Correlation of dose-regimen with the variation coefficient (image noise).
Time frame: 360 seconds
Correlation of acquisition protocol time with the variation coefficient (image noise).
Time frame: 360 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm of Breast and Hodgkin Disease, run by Hospital Sao Rafael at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of body weight with the variation coefficient (image noise). (time frame: 360 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017; AzTrials last refreshed its copy on 26 Oct 2026.