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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02485886
• Date of registration: 26/06/2015
• Prospective Registration: No
• Primary sponsor: Peking Union Medical College Hospital
• Public title: 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
• Scientific title: Safety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
• Date of first enrolment: January 2015
• Target sample size: 20
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02485886
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

China

Contacts

• Name: Zhaohui Zhu, MD
• Affiliation: Peking Union Medical College Hospital

• Name: Zhaihui Zhu, MD

• Name: Zhaohui Zhu, MD

Key inclusion & exclusion 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 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: 68Ga-BMV101

Primary Outcome(s)

Visual and semiquantitative assessment of lesions [Time Frame: 1 year]

Secondary Outcome(s)

Pulse [Time Frame: 24 hours]

Routine urine test [Time Frame: 24 hours]

Serum creatinine [Time Frame: 24 hours]

Routine blood test [Time Frame: 24 hours]

Adverse events collection [Time Frame: 5 days]

Serum alanine aminotransferase [Time Frame: 24 hours]

Serum albumin [Time Frame: 24 hours]

Blood pressure [Time Frame: 24 hours]

Respiration frequency [Time Frame: 24 hours]

Temperature [Time Frame: 24 hours]

Secondary ID(s)

PUMCHNM09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Stanford University