- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Toulouse, Frankrike, 31052
- Institut Claudius Regaud
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)
Tidsram: 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
Tidsram: 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)
Tidsram: 2 years
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2 years
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Frederic COURBON, PhD, Institut Claudius Regaud
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12POUM01
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