Malignant NeoplasmEarly Phase 1NCT06688305
68Ga-NI-FAPI PET/CT: First-in-human Study
A Early Phase 1 study testing 68Ga-NI-FAPI in people with Malignant Neoplasm, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- 68Ga-NI-FAPI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2025
- Phase
- Early 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
- Various solid tumors with available histopathological findings
- Signed informed consent
Who cannot join
- pregnant or lactational women
- who suffered from severe hepatic and renal insufficiency
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
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Jie Zang, PhD, MD, 86-0591-87981619, 15901495106@163.com
Weibing Miao, MD, MD 86-0591-87981618, miaoweibing@126.com
About this study
Official title: 68Ga-NI-FAPI PET/CT: First-in-human Study in Patients With Various Cancers
68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.
Read the detailed description
Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-NI-FAPI is a novel agent incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI in patients with different types of cancer.
- Conditions
- Malignant Neoplasm
- Being tested
- 68Ga-NI-FAPI
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NI-FAPIDrug
Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-NI-FAPI.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NI-FAPI PET/CT | Experimental | PET/CT imaging in patients with malignant tumors: each patient underwent a PET/CT scan after intravenous administration of 68Ga-NI-FAPI. Receives: Drug: 68Ga-NI-FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
Hematologic status, liver function, renal function and General vital signs were recorded before and 1 week after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
Measured: up to 1 week
Secondary outcomes (1)
Dosimetry of normal organs and tumors
The semiquantitative dosimetry will be performed based on PET/CT acquisitions after the first administration of 68Ga-NI-FAPI. The dose delivered to normal organs and tumors will be recorded.
Measured: From right after tracer injection to 150 minutes at post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Aug 2024
- Primary completion31 Jul 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibing Miao, MD, Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688305
- Sponsor's protocol ID
- FirstAHFujian-68Ga-NI-FAPI
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zang J, Cheng H, Luo Y, Jin W, Lai Y, Zheng Q, Peng Y, Kung HF, Zhu L, Ke C, Liu C, Miao W. First-in-human study of a novel bifunctional PET tracer [68Ga]Ga-DOTA-NI-FAPI-04 targeting FAP and hypoxia. Eur J Nucl Med Mol Imaging. 2026 Mar;53(4):2530-2539. doi: 10.1007/s00259-025-07625-0. Epub 2025 Oct 31.
PubMed 41168395
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-NI-FAPI PET/CT: First-in-human Study in Patients With Various Cancers
- ClinicalTrials.gov ID
- NCT06688305
- Acronym / sponsor ID
- FirstAHFujian-68Ga-NI-FAPI
- Conditions
- Malignant Neoplasm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Nov 2024 (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-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.
Detailed description
Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-NI-FAPI is a novel agent incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI in patients with different types of cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NI-FAPI PET/CT | Experimental | Drug: 68Ga-NI-FAPIPET/CT imaging in patients with malignant tumors: each patient underwent a PET/CT scan after intravenous administration of 68Ga-NI-FAPI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Various solid tumors with available histopathological findings
- Signed informed consent
Key exclusion criteria (2 listed)
- pregnant or lactational women
- who suffered from severe hepatic and renal insufficiency
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-NI-FAPIIntravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-NI-FAPI. | Drug | 68Ga-NI-FAPI PET/CT |
Primary outcome
safety and tolerability
Time frame: up to 1 week
Hematologic status, liver function, renal function and General vital signs were recorded before and 1 week after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
1 secondary outcome
Dosimetry of normal organs and tumors
Time frame: From right after tracer injection to 150 minutes at post-injection
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 14 Nov 2024.
- Derived from this study: PubMed 41168395Zang J, Cheng H, Luo Y, Jin W, Lai Y, Zheng Q, Peng Y, Kung HF, Zhu L, Ke C, Liu C, Miao W. First-in-human study of a novel bifunctional PET tracer [68Ga]Ga-DOTA-NI-FAPI-04 targeting FAP and hypoxia. Eur J Nucl Med Mol Imaging. 2026 Mar;53(4):2530-2539. doi: 10.1007/s00259-025-07625-0. Epub 2025 Oct 31.
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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.
Weibing Miao, MD principal investigator
First Affiliated Hospital of Fujian Medical University
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-NI-FAPI in people with Malignant Neoplasm, run by First Affiliated Hospital of Fujian Medical University 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 2 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 14 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?
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?
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 Weibing Miao, MD (+86-0591-87981618, miaoweibing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability (time frame: up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06688305, which also lists 1 linked publication.
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 14 Nov 2024.