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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

68Ga-BMV101

Intervention Type DRUG

68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans.

Interventions

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68Ga-BMV101

68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans.

Intervention Type DRUG

Other Intervention Names

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BMV101 imaging

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No