Pulmonary FibrosisPhase 1NCT05121779
Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT
A Phase 1 study testing 68Ga-FAPI and 18F-FDG in people with Pulmonary Fibrosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
68Ga-fibroblast activating protein inhibitors(FAPI) has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- 68Ga-FAPI and 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2021to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected or confirmed pulmonary fibrosis patients;
- signed written consent.
Who cannot join
- pregnancy;
- breastfeeding;
- known allergy against FAPI
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhaohui Zhu, MD, 86-13611093752, 13611093752@163.com
Jiarou Wang, MS, 86-13628477019, pumc_wangjiarou@student.pumc.edu.cn
About this study
68Ga-fibroblast activating protein inhibitors(FAPI) has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of Pulmonary fibrosis than 18F-FDG PET/CT.
Read the detailed description
Pulmonary fibrosis is a prototype of chronic, progressive, and fibrotic lung disease.Healthy tissue is replaced by altered extracellular matrix and alveolar architecture is destroyed, which leads to decreased lung compliance, disrupted gas exchange, and ultimately respiratory failure and death.Pulmonary fibrosis is diagnosed by identification of a pattern of usual interstitial pneumonia on the basis of radiological or histological criteria in patients without evidence of an alternative cause. Activated fibroblasts are crucial for fibrotic processes in Pulmonary fibrosis. 68Ga-FAPI has been developed as a tumortargeting agent as fibroblast activation protein is overexpressed in cancerassociated fibroblasts and inflammation. Recently，a study shows that FAPI-PET/CT imaging is a promising new imaging modality for Pulmonary fibrosis.This head-to-head comparisons aims to evaluate the severity of pulmonary fibrosis and the therapy response of 68Ga-FAPI-04 compared with 18F-FDG in the same group of pulmonary fibrosis patients.
- Conditions
- Pulmonary Fibrosis
- Being tested
- 68Ga-FAPI, 18F-FDG
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPIDrug
Also called 68Ga-fibroblast activating protein inhibitors
Intravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of pulmonary fibrosis by PET/CT.
18F-FDGDrug
Also called 18F-Fluorodeoxyglucose
Intravenous injection of one dosage of 4.44-5.55 MBq(0.12-0.15mCi)/Kg 18F-FDG. Tracer doses of 18F-FDG will be used to image lesions of pulmonary fibrosis by PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT | Experimental | All patients diagnosed with Lung fibrosis underwent 68Ga-FAPI PET/CT and 18F-FDG PET/CT. Receives: Drug: 68Ga-FAPI; Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value
Sensitivity and Specificity of 68Ga-FAPI PET/CT for Lung fibrosis in comparison with 18F-FDG PET/CT
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
FAPI expression and SUV
Correlation between FAPI expression and SUV in PET
Measured: through study completion, an average of 1 year
therapy response
Change of 68Ga-FAPI PET/CT SUVmax after therapy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start18 Nov 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121779
- Sponsor's protocol ID
- PUMCH-NM-FAPI-PF
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2021
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT
- ClinicalTrials.gov ID
- NCT05121779
- Acronym / sponsor ID
- PUMCH-NM-FAPI-PF
- Conditions
- Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Nov 2021 (actual)
- 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.
68Ga-fibroblast activating protein inhibitors(FAPI) has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of Pulmonary fibrosis than 18F-FDG PET/CT.
Detailed description
Pulmonary fibrosis is a prototype of chronic, progressive, and fibrotic lung disease.Healthy tissue is replaced by altered extracellular matrix and alveolar architecture is destroyed, which leads to decreased lung compliance, disrupted gas exchange, and ultimately respiratory failure and death.Pulmonary fibrosis is diagnosed by identification of a pattern of usual interstitial pneumonia on the basis of radiological or histological criteria in patients without evidence of an alternative cause. Activated fibroblasts are crucial for fibrotic processes in Pulmonary fibrosis. 68Ga-FAPI has been developed as a tumortargeting agent as fibroblast activation protein is overexpressed in cancerassociated fibroblasts and inflammation. Recently，a study shows that FAPI-PET/CT imaging is a promising new imaging modality for Pulmonary fibrosis.This head-to-head comparisons aims to evaluate the severity of pulmonary fibrosis and the therapy response of 68Ga-FAPI-04 compared with 18F-FDG in the same group of pulmonary fibrosis 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-FAPI-04 PET/CT and 18F-FDG PET/CT | Experimental | Drug: 68Ga-FAPI, Drug: 18F-FDGAll patients diagnosed with Lung fibrosis underwent 68Ga-FAPI PET/CT and 18F-FDG PET/CT. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suspected or confirmed pulmonary fibrosis patients;
- signed written consent.
Key exclusion criteria (4 listed)
- pregnancy;
- breastfeeding;
- known allergy against FAPI
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance
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-FAPIAlso: 68Ga-fibroblast activating protein inhibitorsIntravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of pulmonary fibrosis by PET/CT. | Drug | 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT |
| 18F-FDGAlso: 18F-FluorodeoxyglucoseIntravenous injection of one dosage of 4.44-5.55 MBq(0.12-0.15mCi)/Kg 18F-FDG. Tracer doses of 18F-FDG will be used to image lesions of pulmonary fibrosis by PET/CT. | Drug | 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT |
Primary outcome
Diagnostic value
Time frame: through study completion, an average of 1 year
Sensitivity and Specificity of 68Ga-FAPI PET/CT for Lung fibrosis in comparison with 18F-FDG PET/CT
2 secondary outcomes
FAPI expression and SUV
Time frame: through study completion, an average of 1 year
therapy response
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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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.
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 Phase 1 study testing 68Ga-FAPI and 18F-FDG in people with 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Nov 2024. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Zhu, MD (86-13611093752, 13611093752@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value (time frame: through study completion, an average of 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 25 Nov 2024.