NCT02511197

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2015

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 6, 2017

Status Verified

July 1, 2015

Enrollment Period

2.6 years

First QC Date

July 23, 2015

Last Update Submit

April 5, 2017

Conditions

Pulmonary Fibrosis, Unspecified

Keywords

PETlung injuryintegrin receptor

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Adverse events collection

    5 days

  • Routine blood test

    24 hours

  • Serum albumin

    24 hours

  • Routine urine test

    24 hours

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: 68Ga-NOTA-PRGD2Device: PET/CT

Interventions

68Ga-NOTA-PRGD2DRUG

68Ga-NOTA-PRGD2 were injected into the patients before the PET/CT scans

Also known as: 68Ga-NOTA conjugated with dimer PRGD2
68Ga-NOTA-PRGD2 injection & PET/CT scan
PET/CTDEVICE
68Ga-NOTA-PRGD2 injection & PET/CT scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Pulmonary FibrosisLung Injury

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsThoracic InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Zhaohui Zhu, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

+861361109375213611093752@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 29, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 6, 2017

Record last verified: 2015-07

Locations

CN(1)