NCT03183570BefejeződöttKorai 1. fázis
Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT
Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 With [18F]FP-R01-MG-F2 With PET/CT
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. febr. 4.
Rövid összefoglaló (regiszter, angolul)
Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 with \[18F\]FP-R01-MG-F2 with PET/CT
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- Korai 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 21 (tényleges)
- Első benyújtás
- 2017. máj. 8.
- Kezdés
- 2017. nov. 8.
- Elsődleges befejezés
- 2023. ápr. 25.
- Fő szponzor
- Stanford University
- Betegségek
- Idiopátiás tüdőfibrózis
- NCT-szám
- NCT03183570
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · Korai 1. fázis
- Bevont résztvevők: 21
- 2017. nov. 8. és az elsődleges befejezés (2023. ápr. 25.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálatot írja le, nem a te helyzetedet.
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- 1.0 Eligibility Criteria for IPF Patients
- 1.1 Inclusion Criteria
- The following inclusion criteria will be monitored:
- Patient is \>/= 18 years old
- Patient is capable of making an informed decision regarding his/her treatment
- Patient diagnosed with IPF by a pulmonologist according to ATS guidelines
- Patient has high-resolution CT with definite Usual Interstitial Pneumonia (UIP) pattern
- Patient has PFT's within the last 12 months with:
- FVC\<85% predicted
- DLCO\<65% predicted
- FEV1/FCV ratio \>70%
- Patient is able to comply with study procedures
- Scanning Option A OR
- Scanning Option B
- 1.2 Exclusion Criteria
- The following exclusion criteria will be monitored:
- Patient with a serious uncontrolled concurrent medical illness that would limit compliance with study requirements
- Patient has a history of any clinically significant lung disease other than IPF as determined by a pulmonologist
- Patient has had a lung infection of any kind in the last 3 months
- Patient is pregnant or lactating
- 2.0 Eligibility Criteria for PSC Patients
- 2.1 Inclusion Criteria
- The following inclusion criteria will be monitored:
- Patient is \>/= 18 years old
- Patient is capable of making an informed decision regarding his/her treatment
- Patient diagnosed with large duct PSC, based on an abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), and/or percutaneous transhepatic cholangiopancreatography (PTC) in the context of cholestatic liver chemistry
- Patient is able to comply with study procedures
- Scanning Option C
- 2.2 Exclusion Criteria
- The following exclusion criteria will be monitored:
- Patient with a serious uncontrolled concurrent medical illness that would limit compliance with study requirements
- Patient has other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
- Patient has a history of ascending cholangitis within 60 days of screening, as assessed clinically
- Patient has history, current clinical or radiological suspicion, or diagnosis of cholangiocarcinoma, other hepatobiliary malignancy, colorectal cancer, or other abdominal malignancy at any time
- Presence of a percutaneous drain or bile duct stent
- Patient is pregnant or lactating
- 3.0 Eligibility Criteria for Healthy Controls
- 3.1 Inclusion Criteria
- The following inclusion criteria will be monitored:
- Person is \>/= 45 years old
- Person is capable of making an informed decision regarding his/her treatment
- Person is able to comply with study procedures
- Scanning Option A OR
- Scanning Option B
- 3.2 Exclusion Criteria
- The following exclusion criteria will be monitored:
- Person with a serious uncontrolled concurrent medical illness that would limit compliance with study requirements
- Person has a history of any clinically significant lung disease other than IPF as determined by a pulmonologist
- Person had lung infection of any kind in the last 3 months
- Person is pregnant or lactating
- 4.0 Eligibility Criteria for COVID-19 patients
- 4.1 Inclusion Criteria
- The following inclusion criteria will be monitored:
- Patient is \>/= 18 years old
- Patient is capable of making an informed decision regarding his/her treatment
- Patient with a history of SARS-CoV-2 (active or recovered) infection, based on positive RT-PCR testing
- Recovered COVID-19 patient must show evidence of being non-infectious (per Stanford guideline):
- Symptomatic, non-immunocompromised outpatients are considered COVID neg after 10 days or 3 days after symptoms resolve, whichever is longer.
- Severely symptomatic or is immunocompromised outpatients are considered non-infectious after 20 days.
- or RT-PCR negative x2, spaced \>24 hrs apart
- Patient shows or has shown evidence of pulmonary opacities as visualized on chest radiograph or CT
- Patient is able to comply with study procedures and infection control instructions
- Recovered COVID 19 patients: Scanning Option A OR
- Recovered COVID-19 patients: Scanning Option B
- COVID-19 patients with active infection or no evidence of non-active infection: Scanning Option D
- 4.2 Exclusion Criteria
- The following exclusion criteria will be monitored:
- Person with serious uncontrolled concurrent medical illness, such as severe hypoxia, that would limit compliance with study and infection control requirements
- Person with pre-existing fibrosing lung disease (such as but not limited to IPF, NSIP, HP, and sarcoidosis prior to COVID-19 infection).
- Person is pregnant or lactating
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. A betegség oldalán választott várossal távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Stanford University Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Stanford | Egyesült Államok | Ismeretlen állapot |
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