Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

iNOS With Positron Emission Tomography (PET) in Cellular Inflammation. (F-NOS)

22 juli 2020 uppdaterad av: Washington University School of Medicine

Imaging iNOS Activity Using [18F] (+/-) NOS With Positron Emission Tomography (PET) in Cellular Inflammation.

The primary purpose of this study is to measure the level of an enzyme in a patient's heart called inducible nitric oxide synthase(iNOS) using Positron Emission Tomography (PET) imaging with a radioactive tracer called 18F-NOS. These PET results will be compared to tissue results obtained during routine endomyocardial heart biopsy. The enzyme iNOS produces nitric oxide in inflammatory diseases such as acute heart transplant rejection, diabetes, Alzheimer's and cancer. Thus, PET with the radioactive tracer 18F-NOS may be a useful tool for detecting the early stages of these diseases. The safety of 18F-NOS during the study will also be assessed. All PET imaging will be performed with a CTI/Siemens Biograph 40 PET/CT scanner. Protocol was revised to add new imaging modality, Biograph mMR PET-MR scanner in order to investigate new hardware and software in order to optimize scanning procedures in order to refine image quality so that we can apply the findings to future standard clinical scans and research imaging studies. Ten additional status-post OHT patients who are scheduled for standard of care endomyocardial biopsy for allograft rejection surveillance will undergo PET/MR imaging with [18F](+/-)NOS.

Studieöversikt

Detaljerad beskrivning

Nitric oxide (NO) is an important and unique mediator of a variety of physiological and pathological processes. NO is generated from the oxidation of L-arginine to L-citrulline in a two-step process by nitric oxide synthase (NOS) enzymes. In the NOS family, there are two constitutive isozymes of NOS, neuronal NOS (nNOS) and endothelial NOS (eNOS), and one inducible isozyme (iNOS). The three isozymes of NOS are expressed in different tissues to generate NO for specific physiological roles. nNOS generates NO as a neurotransmitter and neuromodulator, mainly in brain and peripheral nerve cells; eNOS regulates blood pressure, and blood flow primarily in vascular endothelial cells. The induction of iNOS occurs by various inflammatory stimuli (e.g., endotoxin) in activated macrophages and other types of cells and plays a crucial role in the host defense and the inflammatory processes.

Normally, the basal level of NO in all parts of the body is very low, mainly due to the constitutive nNOS and eNOS. In contrast, once expressed, iNOS can continue to generate NO in large amounts (up to μM concentrations) for a prolonged period of time. Studies have shown that production of NO by iNOS is implicated in a variety of acute and chronic inflammatory diseases (e.g., sepsis, septic shock, organ transplant rejection, vascular dysfunction in diabetes, asthma, arthritis, multiple sclerosis, and inflammatory diseases of the gut). iNOS activity has also been found in many tumors. Because of the central role of iNOS in NO-related diseases, numerous efforts have been made to develop iNOS inhibitors as pharmaceuticals ranging from the nonselective L-arginine analogues to the selective inhibitors reported recently. Some inhibitors of iNOS have shown promising results in animal models of sepsis, lung inflammation, arthritis, and autoimmune diabetes. Therefore, the development of a radiolabeled iNOS inhibitor for probing iNOS expression in vivo using noninvasive positron emission tomography (PET) imaging will be of tremendous value to the study and treatment of NO-related diseases.

Acute allograft rejection is the major contributor to mortality in patients receiving orthotopic heart transplantation (OHT). Specifically, iNOS has been thought to be the main NOS involved in producing NO that is active in acute cardiac allograft rejection. Up-regulation of iNOS occurs in macrophage cellular infiltrates and later within the graft parenchymal cells. In human cardiac transplantation a positive correlation has shown between iNOS expression and left ventricular contractile dysfunction measured by echocardiography and Doppler techniques. We have recently developed a novel PET radiotracer, [18F](+/-)NOS, designed to measure cellular iNOS activity. This study evaluates the feasibility of the method in OHT patients undergoing surveillance endomyocardial biopsy as part of their normal post-transplant evaluation for potential allograft rejection. More specifically, it will compare the myocardial kinetics of this radiotracer measured by PET with tissue measurements of iNOS measured by immunohistochemistry.

Studietyp

Interventionell

Inskrivning (Faktisk)

26

Fas

  • Tidig fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Missouri
      • Saint Louis, Missouri, Förenta staterna, 63110
        • Washington University School of Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. The OHT patients will be undergoing surveillance endomyocardial biopsy and will Patients 21 years of age or older of either sex, who are status-post OHT and normal healthy volunteers (2 women and 2 men) will be enrolled.be on standard immunosuppressive therapy and anti-hyperlipidemic, anti-hypertensive and anti-diabetic therapies as needed. "Healthy volunteer" is someone who has volunteered to be imaged and who, based on physical exam and baseline electrocardiogram, has no evidence of cardiovascular disease, is not on medication, such as steroids, that will interfere with the accuracy of measuring [18F](+/-)NOS activity and is not under the care of a physician for any active medical conditions.
  2. Able to give informed consent.
  3. Not currently pregnant or nursing: Female subjects must be either: surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of [18F](+/-)NOS) is negative.

Exclusion Criteria:

  1. Patients with an unstable cardiovascular (e.g., severe rejection) or other clinical condition (e.g., active severe infection) that in the opinion of the Principal Investigator or designee or Dr. Ewald precludes participation in the study.
  2. Unable to tolerate 60-90 mins of PET imaging or is claustrophobic.
  3. Normal volunteers with evidence of cardiovascular disease or other diseases based on clinical evaluation and/or blood laboratory tests, which are judged by the Principal Investigator or designee to interfere with accurate determination of the of [18F](+/-)NOS on such measures.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Dosimetry Group
To determine its potential for use in humans, we measured 18F-NOS myocardial activity in patients after orthotopic heart transplantation (OHT) (3 women and 9 men) and normal healthy volunteers (2 women and 2 men), and correlated it with pathologic allograft rejection, tissue iNOS levels, and calculated human radiation dosimetry.
Injection of radiotracer [18F](+/-)NOS for PET imaging and kinetic data analysis
Andra namn:
  • 6-(1/2)(2-18F-fluoropropyl)-4-methylpyridin-2-amine
Experimentell: Kinetic Analysis Group
Measurement of myocardial levels of enzyme nitric oxide synthase(iNOS) using PET and 18F-NOS in post heart transplant patients (5 women and 5 men) undergoing endomyocardial biopsy as part of their normal post-transplant evaluation. Kinetic data of the tracer will be compared with the heart tissue measurements of iNOS measured by immunohistochemistry.
Injection of radiotracer [18F](+/-)NOS for PET imaging and kinetic data analysis
Andra namn:
  • 6-(1/2)(2-18F-fluoropropyl)-4-methylpyridin-2-amine

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
To Measure Free Fatty Acid by Imaging Patients With Increased Levels of iNOS Using [18F](+/-)NOS.
Tidsram: 24-72 hours post [18F](+/-)NOS injection
24-72 hours post [18F](+/-)NOS injection

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To Determine Human Dosimetry in Both Normal Adult Healthy Volunteers and Heart Transplant Patients.
Tidsram: 24-72 hours post [18F](+/-)NOS injection
All subjects will receive a single intravenous administration of 7 mCi of [18F](+/-)NOS followed by dynamic PET/CT imaging
24-72 hours post [18F](+/-)NOS injection

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Robert J Gropler, MD, Washington University School of Medicine

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2009

Primärt slutförande (Faktisk)

1 juni 2012

Avslutad studie (Faktisk)

1 juni 2012

Studieregistreringsdatum

Först inskickad

8 februari 2010

Först inskickad som uppfyllde QC-kriterierna

8 februari 2010

Första postat (Uppskatta)

10 februari 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 augusti 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 juli 2020

Senast verifierad

1 juli 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 09-0986
  • 201106273 (Registeridentifierare: myIRB HRPO)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på [18F](+/-)NOS

3
Prenumerera