Patents With Normal VQ/SPECT3DSPECSTATNCT04332406
Normal Ventilatory and Perfusion Pulmonary Function in TEMP
An observational study of Patents With Normal VQ/SPECT, run by University Hospital, Brest at 1 site in France.
Trial summary
Ventilation - perfusion SPECT is attractive for lung function assessement. Unfortunately, it is very difficult to delineate normal to abnormal areas because of physiological uptake heterogeneity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patents With Normal VQ/SPECT
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2019to 15 Oct 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the department of nuclear medicine of Brest University Hospital, France, for suspected acute pulmonary embolism
Who may be able to join
- normal perfusion and ventilation scans, and no parenchyma or pleural abnormality on low dose CT
- confirmation by a second senior physician
Who cannot join
- Patients with history of pulmonary disease:
- chronic obstruction pulmonary disease,
- previous pulmonary embolism,
- surgery of the lungs
- radiotherapy of the lungs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normal Ventilatory and Perfusion Pulmonary Function in TEMP: Generation of 3D Statistical Maps From Normal Examinations
Ventilation - perfusion SPECT is attractive for lung function assessement. Unfortunately, it is very difficult to delineate normal to abnormal areas because of physiological uptake heterogeneity.
In that context, it would be of interest to build statistical maps from registrered normal studies and propose a new methodology for normal SPECT delineation
Read the detailed description
Patients with normal VQ SPECT-CT will be analysed. After a image proccesing workflow including rigid registration, non rigid registration and normalization, a voxelized mean and standard deviation map will be created. Those maps will be analyzed in regards of physiology and litterature.
- Conditions
- Patents With Normal VQ/SPECT
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior to Anterior and Inferior to Superior uptake relative difference on parametric mean registered SPECT map versus non registered SPECT
parametric mean and standard deviation maps are build from elastic registration of normal lung V/Q SPECT-CT. A ROI based quantitative regional uptake comparison is performed to verify the influence of elastic registration on radiotracer distribution
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start13 Jun 2019
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patents With Normal VQ/SPECTStudies 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
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Yves Le Roux, MD, Phd, Study director, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332406
- Sponsor's protocol ID
- 29BRC19.0129
- Acronym
- 3DSPECSTAT
- Status last verified
- Apr 2020
- First submitted
- 26 Sep 2019
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Ventilatory and Perfusion Pulmonary Function in TEMP: Generation of 3D Statistical Maps From Normal Examinations
- ClinicalTrials.gov ID
- NCT04332406
- Acronym / sponsor ID
- 3DSPECSTAT / 29BRC19.0129
- Conditions
- Patents With Normal VQ/SPECT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 2 Apr 2020 (actual)
- 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.
Ventilation - perfusion SPECT is attractive for lung function assessement. Unfortunately, it is very difficult to delineate normal to abnormal areas because of physiological uptake heterogeneity.
In that context, it would be of interest to build statistical maps from registrered normal studies and propose a new methodology for normal SPECT delineation
Detailed description
Patients with normal VQ SPECT-CT will be analysed. After a image proccesing workflow including rigid registration, non rigid registration and normalization, a voxelized mean and standard deviation map will be created. Those maps will be analyzed in regards of physiology and litterature.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the department of nuclear medicine of Brest University Hospital, France, for suspected acute pulmonary embolism
Key inclusion criteria (2 listed)
- normal perfusion and ventilation scans, and no parenchyma or pleural abnormality on low dose CT
- confirmation by a second senior physician
Key exclusion criteria (5 listed)
- chronic obstruction pulmonary disease,
- previous pulmonary embolism,
- surgery of the lungs
- radiotherapy of the lungs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Posterior to Anterior and Inferior to Superior uptake relative difference on parametric mean registered SPECT map versus non registered SPECT
Time frame: through study completion, an average of 3 months
parametric mean and standard deviation maps are build from elastic registration of normal lung V/Q SPECT-CT. A ROI based quantitative regional uptake comparison is performed to verify the influence of elastic registration on radiotracer distribution
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 2 Apr 2020.
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.
Pierre Yves Le Roux, MD, Phd study director
CHRU BREST
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 Patents With Normal VQ/SPECT, run by University Hospital, Brest at 1 site in France.
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 2 inclusion and 5 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 2 Apr 2020. 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 France. 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?
Posterior to Anterior and Inferior to Superior uptake relative difference on parametric mean registered SPECT map versus non registered SPECT (time frame: through study completion, an average of 3 months). 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 2 Apr 2020.