68Ga-NOTA-PRGD2 PET/CT in Patients With Lung Injury and Pulmonary Fibrosis

Early Phase 1

• Conditions: Pulmonary Fibrosis, Unspecified
• Interventions: Drug: 68Ga-NOTA-PRGD2; Device: PET/CT

• Registration Number: NCT02511197
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-PRGD2 in lung injury (LI) and pulmonary fibrosis (PF) patients. A single dose of nearly 111 MBq 68Ga-NOTA-PRGD2 (≤ 40 µg NOTA-PRGD2) will be intravenously injected into patients with LI/PF. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed Description

The αvβ3-integrin is a transmembrane heterodimeric receptor that mediates cell-cell and cell-extracellular matrix adhesion. The αvβ3-integrin plays a pivotal role in promoting and sustaining angiogenesis and fibrosis. Cyclic arginine-glycine-aspartic acid (RGD) peptide is the key integrin recognition motif that can strongly bind to the αvβ3-integrin, which makes the RGD-based peptides hold a promise for imaging and treatment of diseases characterised with angiogenesis and fibrosis including LI and PF.

Animal study in bleomycin induced lung fibrosis showed good uptake ratio of 68Ga-NOTA-PRGD2 in lung vs background. For interests in clinical translation of 68Ga-NOTA-PRGD2, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 68Ga-NOTA-PRGD2 in patients with LI or PF.

Study Timeline

• Study Start: 2015-05
• Status Verified: 2015-07
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-29
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-06
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients with idiopathic pulmonary fibrosis

• Males and females, ≥18 years old.
• Characteristic clinical signs, symptoms and laboratory tests suggesting the diagnosis of LI/PF.
• The diagnosis of IPF is based on The Centres for Disease Control and Prevention (CDC) criteria for diagnosing LI/PF. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NOTA-PRGD2 injection & PET/CT scan	68Ga-NOTA-PRGD2	The patients were intravenously injected with 68Ga-NOTA-PRGD2 in one dose in nearly 111 MBq and then underwent PET/CT scan 0.5 h later.
68Ga-NOTA-PRGD2 injection & PET/CT scan	PET/CT	The patients were intravenously injected with 68Ga-NOTA-PRGD2 in one dose in nearly 111 MBq and then underwent PET/CT scan 0.5 h later.

Primary Outcome Measures

Name	Time	Method
Semiquantitative assessment of lung lesions	1 year	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.
Visual assessment of lung lesions	1 year	Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician.

Secondary Outcome Measures

Name	Time	Method
Routine blood test	24 hours	Routine blood test of healthy volunteers will be measured before injection and 24 hours after test.
Routine urine test	24 hours	Routine urine test of healthy volunteers will be measured before injection and 24 hours after test.
Adverse events collection	5 days	Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed.
Serum albumin	24 hours	Serum albumin of healthy volunteers will be measured before injection and 24 hours after test.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China