Idiopathic Pulmonary FibrosisEarly Phase 1NCT02485886
68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
A Early Phase 1 study testing 68Ga-BMV101 in people with Idiopathic Pulmonary Fibrosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Inflammation mediated by macrophage infiltration plays a vital role in a diverse range of physiological conditions. In particular, recent evidence suggests this type of macrophage response is important for the disease pathology of pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- 68Ga-BMV101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Zhaihui Zhu, MD, +8613611093752, 13611093752@163.com
About this study
Official title: Safety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
Inflammation mediated by macrophage infiltration plays a vital role in a diverse range of physiological conditions. In particular, recent evidence suggests this type of macrophage response is important for the disease pathology of pulmonary fibrosis. Because cysteine cathepsins are proteases that are highly expressed in antigen presenting cells such as macrophages, they serve as promising biomarkers. Employing non-invasive imaging agents 68Ga-BMV101 that specifically recognize cysteine proteases in immune cells has the potential to not only aid early detection but also significantly aid efforts to monitor progression and patient response to therapy.
Read the detailed description
For interests in clinical translation of 68Ga-BMV101, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 68Ga-BMV101 in patients with idiopathic pulmonary fibrosis (IPF). A single dose of nearly 111 MBq 68Ga-BMV101 will be intravenously injected into healthy volunteers and patients with suspected IPF. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- 68Ga-BMV101
- Keywords
- PET, interstitial pulmonary fibrosis (IPF), cysteine cathepsins, macrophage
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-BMV101Drug
Also called BMV101 imaging
68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-BMV101 injection and PET/CT scan | Experimental | The patients were intravenously injected with 68Ga-BMV101 and underwent PET/CT scan 1 h and 2.5 h after that. Receives: Drug: 68Ga-BMV101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual and semiquantitative assessment of lesions
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. 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.
Measured: 1 year
Secondary outcomes (10)
Blood pressure
Blood pressure of patients will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
Measured: 24 hours
Pulse
Pulse will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Measured: 24 hours
Respiration frequency
Respiration frequency will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Measured: 24 hours
Temperature
Temperature will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Measured: 24 hours
Routine blood test
Routine blood test of patients will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Routine urine test
Routine urine test of patients will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Serum alanine aminotransferase
Serum alanine aminotransferase of patients will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Serum albumin
Serum albumin of patients will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Serum creatinine
Serum creatinine of patients will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Adverse events collection
Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485886
- Sponsor's protocol ID
- PUMCHNM09
- Status last verified
- Jun 2015
- First submitted
- 26 Jun 2015
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02485886
- Acronym / sponsor ID
- PUMCHNM09
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- PET, interstitial pulmonary fibrosis (IPF), cysteine cathepsins, macrophage
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inflammation mediated by macrophage infiltration plays a vital role in a diverse range of physiological conditions. In particular, recent evidence suggests this type of macrophage response is important for the disease pathology of pulmonary fibrosis. Because cysteine cathepsins are proteases that are highly expressed in antigen presenting cells such as macrophages, they serve as promising biomarkers. Employing non-invasive imaging agents 68Ga-BMV101 that specifically recognize cysteine proteases in immune cells has the potential to not only aid early detection but also significantly aid efforts to monitor progression and patient response to therapy.
Detailed description
For interests in clinical translation of 68Ga-BMV101, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 68Ga-BMV101 in patients with idiopathic pulmonary fibrosis (IPF). A single dose of nearly 111 MBq 68Ga-BMV101 will be intravenously injected into healthy volunteers and patients with suspected IPF. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-BMV101 injection and PET/CT scan | Experimental | Drug: 68Ga-BMV101The patients were intravenously injected with 68Ga-BMV101 and underwent PET/CT scan 1 h and 2.5 h after that. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-BMV101Also: BMV101 imaging68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans. | Drug | 68Ga-BMV101 injection and PET/CT scan |
Primary outcome
Visual and semiquantitative assessment of lesions
Time frame: 1 year
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. 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.
10 secondary outcomes
Blood pressure
Time frame: 24 hours
Pulse
Time frame: 24 hours
Respiration frequency
Time frame: 24 hours
Temperature
Time frame: 24 hours
Routine blood test
Time frame: 24 hours
Routine urine test
Time frame: 24 hours
Serum alanine aminotransferase
Time frame: 24 hours
Serum albumin
Time frame: 24 hours
Serum creatinine
Time frame: 24 hours
Adverse events collection
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaohui Zhu, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-BMV101 in people with Idiopathic Pulmonary Fibrosis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Zhu, MD (+8613611093752, 13611093752@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual and semiquantitative assessment of lesions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.