TumorPhase 1/2NCT07464132
Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases
A Phase 1/2 study testing Injection of 68Ga-NI-FAPI in people with Tumor and Cardiovascular Diseases, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to conduct clinical research on [68Ga] Ga-NI-FAPI-04 PET/CT imaging and further investigate its diagnostic value in fibroblast activation related diseases. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor, Cardiovascular Diseases, Pulmonary Fibrosis
- What is being tested?
- Injection of 68Ga-NI-FAPI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2025to 17 Jun 2027
- Phase
- Phase 1/2
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1: 18-85 years old
- 2: Tumor patients can undergo surgery or biopsy to obtain pathological diagnosis
- 3: Ability to understand and sign informed consent forms
- 4: Expected survival period exceeding 6 months and able to receive follow-up
- 5: Healthy volunteers without chronic medical history of hypertension, diabetes, coronary heart disease, kidney disease, tumor, etc
Who cannot join
- 1: Pregnant or lactating women
- 2: Patients allergic to research drug ingredients
- 3: Patients with severe liver and kidney dysfunction (blood creatinine levels exceeding 159 μ mol/L)
- 4: Patients who participate in other clinical trials and interfere with the results of this study
- 5: Patients with severe illness who cannot cooperate with the examination
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, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality
Wang, +86-13021115973, yfwyw1999@126.com
About this study
The purpose of this study is to conduct clinical research on [68Ga] Ga-NI-FAPI-04 PET/CT imaging and further investigate its diagnostic value in fibroblast activation related diseases.
- Conditions
- Tumor, Cardiovascular Diseases, Pulmonary Fibrosis, Rheumatic Immune Diseases Involving Large Blood Vessels, Hypertrophic Cardiomyopathy (HCM), Other Hypoxic and Fibroblast Activated Diseases
- Being tested
- Injection of 68Ga-NI-FAPI
- Medical subject headings
- Neoplasms, Cardiovascular Diseases, Pulmonary Fibrosis, Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of 68Ga-NI-FAPIDrug
Subjects were injected with 68Ga-NI-FAPI at 0.4-0.5mci/kg body weight
| Study group | Role | What they receive |
|---|---|---|
| NI-FAPI group | Experimental | Injection of [68Ga]Ga-NI-FAPI Receives: Drug: Injection of 68Ga-NI-FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of PET/CT Images of [68Ga] Ga-NI-FAPI-04
Semi quantitative analysis (measuring lesion standard uptake value (SUV), then calculating lesion SUV to liver/blood pool SUV ratio)
Measured: Within 30-120 minutes after intravenous injection of imaging agent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start17 Dec 2025
- Primary completion17 Feb 2027 (estimated)
- Study completion17 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaohui Zhu, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464132
- Sponsor's protocol ID
- I-25PJ0568
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases
- ClinicalTrials.gov ID
- NCT07464132
- Acronym / sponsor ID
- I-25PJ0568
- Conditions
- Tumor, Cardiovascular Diseases, Pulmonary Fibrosis, Rheumatic Immune Diseases Involving Large Blood Vessels, Hypertrophic Cardiomyopathy (HCM), Other Hypoxic and Fibroblast Activated Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 17 Feb 2027 (estimated)
- Study completion
- 17 Jun 2027 (estimated)
- First posted
- 11 Mar 2026 (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.
The purpose of this study is to conduct clinical research on [68Ga] Ga-NI-FAPI-04 PET/CT imaging and further investigate its diagnostic value in fibroblast activation related diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NI-FAPI group | Experimental | Drug: Injection of 68Ga-NI-FAPIInjection of [68Ga]Ga-NI-FAPI |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1: 18-85 years old
- 2: Tumor patients can undergo surgery or biopsy to obtain pathological diagnosis
- 3: Ability to understand and sign informed consent forms
- 4: Expected survival period exceeding 6 months and able to receive follow-up
- 5: Healthy volunteers without chronic medical history of hypertension, diabetes, coronary heart disease, kidney disease, tumor, etc
Key exclusion criteria (5 listed)
- 1: Pregnant or lactating women
- 2: Patients allergic to research drug ingredients
- 3: Patients with severe liver and kidney dysfunction (blood creatinine levels exceeding 159 μ mol/L)
- 4: Patients who participate in other clinical trials and interfere with the results of this study
- 5: Patients with severe illness who cannot cooperate with the examination
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 |
|---|---|---|
| Injection of 68Ga-NI-FAPISubjects were injected with 68Ga-NI-FAPI at 0.4-0.5mci/kg body weight | Drug | NI-FAPI group |
Primary outcome
Analysis of PET/CT Images of [68Ga] Ga-NI-FAPI-04
Time frame: Within 30-120 minutes after intravenous injection of imaging agent
Semi quantitative analysis (measuring lesion standard uptake value (SUV), then calculating lesion SUV to liver/blood pool SUV ratio)
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 11 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Injection of 68Ga-NI-FAPI in people with Tumor and Cardiovascular Diseases, 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 5 inclusion and 5 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 11 Mar 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zhu (+86-13021115973, yfwyw1999@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of PET/CT Images of [68Ga] Ga-NI-FAPI-04 (time frame: Within 30-120 minutes after intravenous injection of imaging agent). 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 11 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.