search
Back to results

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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-BMV101
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Idiopathic Pulmonary Fibrosis focused on measuring PET, interstitial pulmonary fibrosis (IPF), cysteine cathepsins, macrophage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-BMV101 injection and PET/CT scan

Arm Description

The patients were intravenously injected with 68Ga-BMV101 and underwent PET/CT scan 1 h and 2.5 h after that.

Outcomes

Primary Outcome Measures

Visual and semiquantitative assessment of lesions
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

Blood pressure
Blood pressure of patients will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
Pulse
Pulse will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Respiration frequency
Respiration frequency will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Temperature
Temperature will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Routine blood test
Routine blood test of patients will be measured at two time points: right before injection and 24 hours after treatment.
Routine urine test
Routine urine test of patients will be measured at two time points: right before injection and 24 hours after treatment.
Serum alanine aminotransferase
Serum alanine aminotransferase of patients will be measured at two time points: right before injection and 24 hours after treatment.
Serum albumin
Serum albumin of patients will be measured at two time points: right before injection and 24 hours after treatment.
Serum creatinine
Serum creatinine of patients will be measured at two time points: right before injection and 24 hours after treatment.
Adverse events collection
Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed.

Full Information

First Posted
June 26, 2015
Last Updated
April 5, 2017
Sponsor
Peking Union Medical College Hospital
Collaborators
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT02485886
Brief Title
68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
Official Title
Safety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
PET, interstitial pulmonary fibrosis (IPF), cysteine cathepsins, macrophage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-BMV101 injection and PET/CT scan
Arm Type
Experimental
Arm Description
The patients were intravenously injected with 68Ga-BMV101 and underwent PET/CT scan 1 h and 2.5 h after that.
Intervention Type
Drug
Intervention Name(s)
68Ga-BMV101
Other Intervention Name(s)
BMV101 imaging
Intervention Description
68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans.
Primary Outcome Measure Information:
Title
Visual and semiquantitative assessment of lesions
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure of patients will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
Time Frame
24 hours
Title
Pulse
Description
Pulse will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Time Frame
24 hours
Title
Respiration frequency
Description
Respiration frequency will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Time Frame
24 hours
Title
Temperature
Description
Temperature will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Time Frame
24 hours
Title
Routine blood test
Description
Routine blood test of patients will be measured at two time points: right before injection and 24 hours after treatment.
Time Frame
24 hours
Title
Routine urine test
Description
Routine urine test of patients will be measured at two time points: right before injection and 24 hours after treatment.
Time Frame
24 hours
Title
Serum alanine aminotransferase
Description
Serum alanine aminotransferase of patients will be measured at two time points: right before injection and 24 hours after treatment.
Time Frame
24 hours
Title
Serum albumin
Description
Serum albumin of patients will be measured at two time points: right before injection and 24 hours after treatment.
Time Frame
24 hours
Title
Serum creatinine
Description
Serum creatinine of patients will be measured at two time points: right before injection and 24 hours after treatment.
Time Frame
24 hours
Title
Adverse events collection
Description
Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu, MD
Phone
+8613611093752
Email
13611093752@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaihui Zhu, MD
Phone
+8613611093752
Email
13611093752@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs