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Imaging Lung Function Using Oxygen Enhanced MRI

20 sierpnia 2014 zaktualizowane przez: Hal C Charles

A Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast Agent

The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to allow an effect size estimate to power future studies.

Przegląd badań

Status

Zakończony

Interwencja / Leczenie

Szczegółowy opis

This is an open label study expanding on work by other groups in animals, ex-vivo human lungs and human subjects. Both 2-dimensional and 3-dimensional images will be obtained using 1H MRI comparing images obtained while breathing oxygen to those obtained breathing room air.

Objectives

  • To determine if 1H magnetic resonance images of the human lung and airways can be obtained in both single breath-hold and gated breathing imaging studies with adequate signal level and image contrast to extract regional lung functional information with oxygen as a contrast agent.
  • To determine the short term reproducibility of the lung functional imaging in a subset of subjects (5 control subjects and 5 subjects with lung disease) with repeat MRI studies (Visit 2) at a time point ≥ 1 week to ≤ 4 weeks from Visit 1

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

15

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • North Carolina
      • Durham, North Carolina, Stany Zjednoczone, 27705
        • Duke University Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 90 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria for Lung and/or Airway Disease

  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

    1. Subjects must be ≥ 18 years of age;
    2. Evidence of lung disease or injury by medical history, physical exam, and/or clinical laboratories;

      • COPD
      • Asthma
      • Pre/Post Lung Transplant
      • Cystic Fibrosis
      • Emphysema/Other Small Airways Diseases
      • Lung Transplant
    3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
    4. Subjects who are willing and able to comply with scheduled visits and other trial procedures.

Exclusion Criteria for Subjects with Lung and/or Airway Disease:

Subjects presenting with any of the following will not be included in the trial:

  1. Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
  2. Unable to receive 100% oxygen by breathing because of potential hypercapnia ( SpO2 <90% or FEV1 < 1 L);
  3. Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
  4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial. This determination is made by the referring physician based on standard clinical practice.
  5. Female; women of childbearing potential must have a confirmed negative urine pregnancy test on the day of the MR scan, prior to the MRI scan.

Inclusion Criteria for Normal Subjects Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

  1. Subjects must be ≥ 18 years of age;
  2. Non-smokers, ex-smokers with normal pulmonary function test by spirometry;
  3. No Evidence of prior lung disease or lung injury by medical history, physical exam, and/or clinical laboratories;
  4. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
  5. Subjects who are willing and able to comply with scheduled visits and other trial procedures.

Exclusion Criteria for Normal Subjects

Subjects presenting with any of the following will not be included in the trial:

  1. Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
  2. Unable to receive 100% oxygen by breathing because of potential hypercapnia (SpO2 <90% or FEV1 < 1 L) (Note, we consider this highly unlikely in a 'normal' subject);
  3. Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
  4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
  5. Female; women of childbearing potential must have a confirmed negative urine pregnancy test on the day of the MR scan, prior to the MRI scan.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Diagnostyczny
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Normal Subject
Each subject will receive oxygen as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures. The subjects will receive the gas by breathing room air interleaved with oxygen using a standard Douglas Bag system. No additional drug products, investigational or otherwise will be provided in this study.
At the study visits, MRI 'studies' will be performed using the same MR scanner (a 3.0-Tesla (T) TRIO MRI system (Siemens Medical Systems)). Lung morphology and function will be acquired using conventional 1H MRI followed by 1H MRI with oxygen as a gaseous contrast agent. For both series the subject will lie down in a supine position on the magnet bed with a standard 1H Torso coil for imaging. Subjects are scanned on room air and then the subjects are switched from room air to 100% oxygen and exhaled O2/CO2 are monitored (Oxigraf Capnograph) until steady state is achieved (in our experience ~ 1-2 minutes). The 100% oxygen MRI imaging is commenced (the average exposure time is usually 5-6 minutes with a maximum exposure of 15 minutes) after which the subjects are switched to room air. After steady state is achieved a second room air scan is completed.
Inne nazwy:
  • tlen
Eksperymentalny: Subjects with Lung/or Airway Disease
Each subject will receive oxygen as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures. The subjects will receive the gas by breathing room air interleaved with oxygen using a standard Douglas Bag system. No additional drug products, investigational or otherwise will be provided in this study.
At the study visits, MRI 'studies' will be performed using the same MR scanner (a 3.0-Tesla (T) TRIO MRI system (Siemens Medical Systems)). Lung morphology and function will be acquired using conventional 1H MRI followed by 1H MRI with oxygen as a gaseous contrast agent. For both series the subject will lie down in a supine position on the magnet bed with a standard 1H Torso coil for imaging. Subjects are scanned on room air and then the subjects are switched from room air to 100% oxygen and exhaled O2/CO2 are monitored (Oxigraf Capnograph) until steady state is achieved (in our experience ~ 1-2 minutes). The 100% oxygen MRI imaging is commenced (the average exposure time is usually 5-6 minutes with a maximum exposure of 15 minutes) after which the subjects are switched to room air. After steady state is achieved a second room air scan is completed.
Inne nazwy:
  • tlen

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Image Quality
Ramy czasowe: one exposure
Assessment of image quality of oxygen enhanced MR images: Signal to Noise Ratio, Dynamic Range of Ratio/Difference Images
one exposure

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Cecil Charles, PhD, Duke University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2012

Zakończenie podstawowe (Rzeczywisty)

1 września 2012

Ukończenie studiów (Rzeczywisty)

1 września 2012

Daty rejestracji na studia

Pierwszy przesłany

16 listopada 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 listopada 2012

Pierwszy wysłany (Oszacować)

21 listopada 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

22 sierpnia 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 sierpnia 2014

Ostatnia weryfikacja

1 listopada 2012

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • Pro00024828
  • DIAL1001002 (Inny identyfikator: Duke University Medical Center)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Medical Grade Oxygen

3
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