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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Safety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02485886
• Other study ID #: PUMCHNM09
• Status: Recruiting
• Phase: Early Phase 1
• First received: June 26, 2015
• Last updated: April 5, 2017
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2015
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD
• Phone: +8613611093752
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Stanford University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Pulse	Pulse will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.	24 hours
Secondary	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
Secondary	Temperature	Temperature will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Serum albumin	Serum albumin of patients will be measured at two time points: right before injection and 24 hours after treatment.	24 hours
Secondary	Serum creatinine	Serum creatinine of patients will be measured at two time points: right before injection and 24 hours after treatment.	24 hours
Secondary	Adverse events collection	Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed.	5 days