Patents With Normal VQ/SPECT Clinical Trial
— 3DSPECSTATOfficial title:
Normal Ventilatory and Perfusion Pulmonary Function in TEMP: Generation of 3D Statistical Maps From Normal Examinations
| NCT number | NCT04332406 |
| Other study ID # | 29BRC19.0129 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 13, 2019 |
| Est. completion date | October 15, 2019 |
| Verified date | April 2020 |
| Source | University Hospital, Brest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 96 |
| Est. completion date | October 15, 2019 |
| Est. primary completion date | October 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - normal perfusion and ventilation scans, and no parenchyma or pleural abnormality on low dose CT - confirmation by a second senior physician Exclusion Criteria: Patients with history of pulmonary disease: - chronic obstruction pulmonary disease, - previous pulmonary embolism, - surgery of the lungs - radiotherapy of the lungs |
| Country | Name | City | State |
|---|---|---|---|
| France | Médecine nucléaire - Hôpital Morvan (CHRU de Brest) | Brest |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Brest |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | through study completion, an average of 3 months |