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

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.

Study Overview

• Status: Unknown
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: 68Ga-BMV101

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: BMV101 imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Stanford University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): June 30, 2015

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: PET; macrophage; interstitial pulmonary fibrosis (IPF); cysteine cathepsins
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: PUMCHNM09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO