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Trial record 62 of 317 for:    "Pulmonary Fibrosis, Idiopathic"

68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02485886
Recruitment Status : Unknown
Verified June 2015 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : June 30, 2015
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: 68Ga-BMV101 Early Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: 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.
Drug: 68Ga-BMV101
68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans.
Other Name: BMV101 imaging




Primary Outcome Measures :
  1. Visual and semiquantitative assessment of lesions [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 24 hours ]
    Blood pressure of patients will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.

  2. Pulse [ Time Frame: 24 hours ]
    Pulse will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.

  3. Respiration frequency [ Time Frame: 24 hours ]
    Respiration frequency will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.

  4. Temperature [ Time Frame: 24 hours ]
    Temperature will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.

  5. Routine blood test [ Time Frame: 24 hours ]
    Routine blood test of patients will be measured at two time points: right before injection and 24 hours after treatment.

  6. Routine urine test [ Time Frame: 24 hours ]
    Routine urine test of patients will be measured at two time points: right before injection and 24 hours after treatment.

  7. Serum alanine aminotransferase [ Time Frame: 24 hours ]
    Serum alanine aminotransferase of patients will be measured at two time points: right before injection and 24 hours after treatment.

  8. Serum albumin [ Time Frame: 24 hours ]
    Serum albumin of patients will be measured at two time points: right before injection and 24 hours after treatment.

  9. Serum creatinine [ Time Frame: 24 hours ]
    Serum creatinine of patients will be measured at two time points: right before injection and 24 hours after treatment.

  10. Adverse events collection [ Time Frame: 5 days ]
    Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485886


Contacts
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Contact: Zhaohui Zhu, MD +8613611093752 13611093752@163.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Zhaihui Zhu, MD    +8613611093752    13611093752@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Stanford University
Investigators
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Principal Investigator: Zhaohui Zhu, MD Peking Union Medical College Hospital

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02485886     History of Changes
Other Study ID Numbers: PUMCHNM09
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Peking Union Medical College Hospital:
PET
interstitial pulmonary fibrosis (IPF)
cysteine cathepsins
macrophage

Additional relevant MeSH terms:
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Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial