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

Primary Purpose

Pulmonary Fibrosis, Unspecified

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NOTA-PRGD2
PET/CT
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Fibrosis, Unspecified focused on measuring PET, lung injury, integrin receptor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-NOTA-PRGD2 injection & PET/CT scan

Arm Description

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.

Outcomes

Primary Outcome Measures

Visual assessment of lung lesions
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician.
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.

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2015
Last Updated
April 5, 2017
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02511197
Brief Title
68Ga-NOTA-PRGD2 PET/CT in Patients With Lung Injury and Pulmonary Fibrosis
Official Title
Safety and Diagnostic Performance of 68Ga-NOTA-PRGD2 PET/CT in Patients With Lung Injury and Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis, Unspecified
Keywords
PET, lung injury, integrin receptor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-NOTA-PRGD2 injection & PET/CT scan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
68Ga-NOTA-PRGD2
Other Intervention Name(s)
68Ga-NOTA conjugated with dimer PRGD2
Intervention Description
68Ga-NOTA-PRGD2 were injected into the patients before the PET/CT scans
Intervention Type
Device
Intervention Name(s)
PET/CT
Primary Outcome Measure Information:
Title
Visual assessment of lung lesions
Description
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician.
Time Frame
1 year
Title
Semiquantitative assessment of lung lesions
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events collection
Description
Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed.
Time Frame
5 days
Title
Routine blood test
Description
Routine blood test of healthy volunteers will be measured before injection and 24 hours after test.
Time Frame
24 hours
Title
Serum albumin
Description
Serum albumin of healthy volunteers will be measured before injection and 24 hours after test.
Time Frame
24 hours
Title
Routine urine test
Description
Routine urine test of healthy volunteers will be measured before injection and 24 hours after test.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu, MD
Phone
+8613611093752
Email
13611093752@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaihui Zhu, MD
Phone
+8613611093752
Email
13611093752@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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