68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
5. april 2017 oppdatert av: Peking Union Medical College Hospital
Safety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
Inflammation mediated by macrophage infiltration plays a vital role in a diverse range of physiological conditions.
In particular, recent evidence suggests this type of macrophage response is important for the disease pathology of pulmonary fibrosis.
Because cysteine cathepsins are proteases that are highly expressed in antigen presenting cells such as macrophages, they serve as promising biomarkers.
Employing non-invasive imaging agents 68Ga-BMV101 that specifically recognize cysteine proteases in immune cells has the potential to not only aid early detection but also significantly aid efforts to monitor progression and patient response to therapy.
Studieoversikt
Detaljert beskrivelse
For interests in clinical translation of 68Ga-BMV101, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 68Ga-BMV101 in patients with idiopathic pulmonary fibrosis (IPF).
A single dose of nearly 111 MBq 68Ga-BMV101 will be intravenously injected into healthy volunteers and patients with suspected IPF.
Visual and semiquantitative method will be used to assess the PET/CT images.
Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the volunteers.
Adverse events will also be observed in the patients.
Studietype
Intervensjonell
Registrering (Forventet)
20
Fase
- Tidlig fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Beijing, Kina, 100730
- Rekruttering
- Peking Union Medical College Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
Patients with idiopathic pulmonary fibrosis
- Males and females, ≥18 years old
- Characteristic clinical signs, symptoms and laboratory tests suggesting the diagnosis of IPF.
- The diagnosis of IPF is based on The Centres for Disease Control and Prevention (CDC) criteria for diagnosing IPF. They rely on a combination of clinical, radiological, operative and histological findings, in addition to results of other laboratory tests.
Exclusion Criteria:
- Females planning to bear a child recently or with childbearing potential
- Renal function: serum creatinine >3.0 mg/dL (270 μM/L)
- Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
- Known severe allergy or hypersensitivity to IV radiographic contrast.
- Patients not able to enter the bore of the PET/CT scanner.
- Inability to lie still for the entire imaging time because of cough, pain, etc.
- Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
- Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 68Ga-BMV101 injection and PET/CT scan
The patients were intravenously injected with 68Ga-BMV101 and underwent PET/CT scan 1 h and 2.5 h after that.
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68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Visual and semiquantitative assessment of lesions
Tidsramme: 1 year
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Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician.
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of lungs will be measured.
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1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Innsamling av uønskede hendelser
Tidsramme: 5 dager
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Bivirkninger innen 5 dager etter injeksjon og skanning av pasienter og pasienter vil bli fulgt og vurdert.
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5 dager
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Blood pressure
Tidsramme: 24 hours
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Blood pressure of patients will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
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24 hours
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Pulse
Tidsramme: 24 hours
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Pulse will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
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24 hours
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Respiration frequency
Tidsramme: 24 hours
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Respiration frequency will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
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24 hours
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Temperature
Tidsramme: 24 hours
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Temperature will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
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24 hours
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Routine blood test
Tidsramme: 24 hours
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Routine blood test of patients will be measured at two time points: right before injection and 24 hours after treatment.
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24 hours
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Routine urine test
Tidsramme: 24 hours
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Routine urine test of patients will be measured at two time points: right before injection and 24 hours after treatment.
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24 hours
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Serum alanine aminotransferase
Tidsramme: 24 hours
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Serum alanine aminotransferase of patients will be measured at two time points: right before injection and 24 hours after treatment.
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24 hours
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Serum albumin
Tidsramme: 24 hours
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Serum albumin of patients will be measured at two time points: right before injection and 24 hours after treatment.
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24 hours
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Serum creatinine
Tidsramme: 24 hours
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Serum creatinine of patients will be measured at two time points: right before injection and 24 hours after treatment.
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24 hours
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2015
Primær fullføring (Forventet)
1. desember 2017
Studiet fullført (Forventet)
1. desember 2017
Datoer for studieregistrering
Først innsendt
26. juni 2015
Først innsendt som oppfylte QC-kriteriene
26. juni 2015
Først lagt ut (Anslag)
30. juni 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. april 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. april 2017
Sist bekreftet
1. juni 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PUMCHNM09
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .