- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01720186
Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer (SPI COHERENCE)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Toulouse, Frankrig, 31052
- Institut Claudius Regaud
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Patient for whom there is an indication of PET/CT 18FDG imaging for thoracic oncology ; this indication is consistent with the Standard Options Recommendations or was validated during Multidisciplinary Consultation Meeting :
- Either an extension assessment of non-small cell lung cancer;
- Either the characterization of single pulmonary nodule; Or - the definition of the target volume in radiotherapy.
Patient who meets the following criteria to be eligible for an PET/CT imaging:
- Patient able to maintain a supine position for 60 minutes
- Patient with no bronchopulmonary infection and with no upper aero digestive tract acute infection in progress (increased risk of false positives)
- Age ≥ 18 years
- WHO ≤ 1
- Well-informed written consent signed by the patient and collected before any specific procedure in the study
- Patient member in a national insurance scheme
Exclusion Criteria:
- Patient with a bronchial carcinoid or bronchoalveolar cancer
- Patient with acute bronchopneumopathy
- Not stabilized diabetic patient
- Patient with an absolute indication against spirometry: ongoing pneumothorax or within the previous month, pleural biopsy or puncture within the previous month, hemoptysis, severe asthma, tuberculosis
- Any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain
- Any usual formal indication against imaging examination PET/CT (important claustrophobia)
- Patient unable to follow study procedures
- Pregnant women or nursing mothers can not participate in the study
- Men and women of childbearing age must use effective contraception at study entry and throughout the study
- Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator
- Patient under legal guardianship
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: SPI Medical device
SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax.
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Aktiv komparator: reference medical device : RPM
Reference medical device (RPM) used simultaneously during PET/CT 4D imaging in a synchronized mode centered on the thorax.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )
Tidsramme: 2 years
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feasibility is evaluated in a composite end point (success will be obtained in case of concomitant success of the 4 sub-criteria assessment):
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2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)
Tidsramme: 2 years
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2 years
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Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm
Tidsramme: 2 years
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dtRpm = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle
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2 years
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Measure of BTVrpm (= biologic tumoral volume)
Tidsramme: 2 years
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2 years
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Frederic COURBON, PhD, Institut Claudius Regaud
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12POUM01
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