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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Fibrosis, Unspecified
• Intervention / Treatment: Device: PET/CT; Drug: 68Ga-NOTA-PRGD2

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 Type: Interventional
• Enrollment (Anticipated): 30
• 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-NOTA-PRGD2 injection & PET/CT scan; 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.	Device: PET/CT; Drug: 68Ga-NOTA-PRGD2; 68Ga-NOTA-PRGD2 were injected into the patients before the PET/CT scans; Other Names: 68Ga-NOTA conjugated with dimer PRGD2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual assessment of lung lesions	Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician.	1 year
Semiquantitative assessment of lung lesions	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
Routine blood test	Routine blood test of healthy volunteers will be measured before injection and 24 hours after test.	24 hours
Serum albumin	Serum albumin of healthy volunteers will be measured before injection and 24 hours after test.	24 hours
Routine urine test	Routine urine test of healthy volunteers will be measured before injection and 24 hours after test.	24 hours

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 29, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: PET; lung injury; integrin receptor
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Fibrosis; Pulmonary Fibrosis; Lung Injury
• Other Study ID Numbers: PUMCHNM10