TumorPhase 1NCT07144085
Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.
A Phase 1 study testing 68Ga-FXX489, Positron Emission Tomography (PET) imaging and Gallium-68 labelled (68Ga-) FAP-2286 in people with Tumor and Metastatic Cancer, run by Yi Tian at 1 site in China.
Trial summary
A new radiotracer, 68Ga-FXX489 (NNS309), has been developed for tracking fibroblast activation protein (FAP) and visualizing the tumor stroma. The purpose of the study is to explore the diagnostic value of 68Ga-FXX489 (NNS309) PET/CT imaging in oncological diseases, to assess its safety, imaging characteristics, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tumor, Metastatic Cancer
- What is being tested?
- 68Ga-FXX489, Positron Emission Tomography (PET) imaging and Gallium-68 labelled (68Ga-) FAP-2286
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2025to 30 Jul 2027
- 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
- Patients with a high suspicion of oncological diseases.
- Age: 18-80 years, no gender restriction, able to express themselves independently, and willing to participate in this study with a signed informed consent form.
Who cannot join
- Failure to sign the informed consent form.
- Severe visual or auditory impairment, cognitive disorders, or patients with claustrophobia who cannot communicate effectively.
- Severe cardiac dysfunction, cardiac function class III-IV.
- Renal failure (serum creatinine level > 1.2 mg/dl).
- Allergy to alcohol.
- Use of drugs within 1 week prior to the examination that can cause a disulfiram-like reaction with alcohol, such as penicillins, cephalosporins, or cefotetan.
- Known pregnancy.
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
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Xuena Li, 0086-18040099351, lixuenacmunm@163.com
About this study
A new radiotracer, 68Ga-FXX489 (NNS309), has been developed for tracking fibroblast activation protein (FAP) and visualizing the tumor stroma. The purpose of the study is to explore the diagnostic value of 68Ga-FXX489 (NNS309) PET/CT imaging in oncological diseases, to assess its safety, imaging characteristics, and biodistribution after administration.
Read the detailed description
Initially the investigator(s) will focus on imaging pancreatic cancer, lung cancer, breast cancer, gastric cancer, colorectal cancer.
STUDY AIMS
- Determine the dosimetry for gallium-68 labelled 68Ga- FXX489(NNS309).
- Evaluate the uptake and retention of radiotracer in a variety of solid tumors with 68Ga- FXX489(NNS309).
- Evaluate the ability of FAP-2286 to detect metastatic disease. PRIMARY OBJECTIVES
1.Safety of 68Ga- FXX489(NNS309). 2.determine the organ dosimetry of 68Ga- FXX489(NNS309). 3.To assess the feasibility of detecting tumor uptake using FXX489(NNS309). 4.To determine the feasibility of detecting metastatic disease using FXX489(NNS309).
EXPLORATORY OBJECTIVES
- Determine impact of administered dose of FXX489(NNS309) on image quality.
- Compare the feasibility of detecting tumor uptake using FXX489(NNS309) and FAP-2286 .
A repeat radiolabeled FXX489(NNS309) PET may be obtained after initiation of subsequent treatment in order to evaluate changes in PET uptake due to treatment effect. Patients will be followed for up to 3 days after the injection of radiolabeled ligand for evaluation of adverse events.
- Conditions
- Tumor, Metastatic Cancer
- Being tested
- 68Ga-FXX489, Positron Emission Tomography (PET) imaging, Gallium-68 labelled (68Ga-) FAP-2286
- Keywords
- FAP, CAF
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FXX489Drug
The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging.
Positron Emission Tomography (PET) imagingProcedure or surgery
Participants will be scanned for approximately 30 to 45 minutes.
Gallium-68 labelled (68Ga-) FAP-2286Drug
The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging.
| Study group | Role | What they receive |
|---|---|---|
| Tumor population | Experimental | PET imaging will begin 30 +/-10 minutes, 60 +/-15 minutes and 120 +/-20 minutes after injection of 68Ga-FXX489 or 68Ga-FAP-2286 or 18F-FDG. Receives: Drug: 68Ga-FXX489; Procedure: Positron Emission Tomography (PET) imaging; Drug: Gallium-68 labelled (68Ga-) FAP-2286 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of participants with treatment-emergent adverse events
The frequency and severity of treatment emergent adverse events following FXX489(NNS306) injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Measured: Up to 3 days
Proportion of radiation-absorbed doses of radiolabeled FAP-2286.
Volumes of interest of 68Ga- will be drawn around regions identified on the scans, including the liver, spleen, kidneys, urinary bladder, the central sacrum (for hematopoietic marrow) and whole body. Data will be fitted using the Simulation, Analysis, and Modeling Software II (SAAM II) software. Time integrals of activity will be entered into the Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM) software, using the reference adult model. The results from all patients enrolled will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs
Measured: Up to 3 days
Standardized Uptake Values (SUVs)
The maximum Standardized Uptake Value (SUVmax) will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity.
Measured: Up to 3 days
Tumor-to-background (TBR) Ratio
TBR ratios will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity. The median and range of the measured TBRs will be reported across all RECIST measurable lesions as a table broken down by location (organ metastases, nodal metastases and bone metastases).
Measured: Up to 3 days
Proportion of positive lesions on FXX489(NNS306) PET
Conventional imaging will be reviewed in conjunction with the FXX489(NNS306) PET images. Lesions will be characterized as positive on FXX489(NNS306) PET if uptake is greater than 1.5 times higher than mediastinal blood pool and uptake cannot be attributed to physiologic or inflammatory reasons. Conventional imaging will be interpreted as positive by each lesion if the short axis dimension of lymph nodes is greater than 1 centimeter (cm), and organ metastases measure greater than 1 cm in long axis. The gold standard will be the combination of conventional imaging and FXX489(NNS306) PET in combination with clinical follow-up and histopathology (if available). The number of lesions detected by each modality will be compared and sensitivity will be computed. Since this is a proof-of-concept study, it is not powered for the test of agreement. Nevertheless, the agreement will be tested using McNemar's test.
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start11 Sep 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Tian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Tian, First Hospital of China Medical University
- Investigators
- Xuena Li, Study director, Department of Nuclear Medicine, The First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144085
- Sponsor's protocol ID
- [2025]670
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.
- ClinicalTrials.gov ID
- NCT07144085
- Acronym / sponsor ID
- [2025]670
- Conditions
- Tumor, Metastatic Cancer
- Keywords
- FAP, CAF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yi TianUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 27 Aug 2025 (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.
A new radiotracer, 68Ga-FXX489 (NNS309), has been developed for tracking fibroblast activation protein (FAP) and visualizing the tumor stroma. The purpose of the study is to explore the diagnostic value of 68Ga-FXX489 (NNS309) PET/CT imaging in oncological diseases, to assess its safety, imaging characteristics, and biodistribution after administration.
Detailed description
Initially the investigator(s) will focus on imaging pancreatic cancer, lung cancer, breast cancer, gastric cancer, colorectal cancer.
STUDY AIMS
- Determine the dosimetry for gallium-68 labelled 68Ga- FXX489(NNS309).
- Evaluate the uptake and retention of radiotracer in a variety of solid tumors with 68Ga- FXX489(NNS309).
- Evaluate the ability of FAP-2286 to detect metastatic disease. PRIMARY OBJECTIVES
1.Safety of 68Ga- FXX489(NNS309). 2.determine the organ dosimetry of 68Ga- FXX489(NNS309). 3.To assess the feasibility of detecting tumor uptake using FXX489(NNS309). 4.To determine the feasibility of detecting metastatic disease using FXX489(NNS309).
EXPLORATORY OBJECTIVES
- Determine impact of administered dose of FXX489(NNS309) on image quality.
- Compare the feasibility of detecting tumor uptake using FXX489(NNS309) and FAP-2286 .
A repeat radiolabeled FXX489(NNS309) PET may be obtained after initiation of subsequent treatment in order to evaluate changes in PET uptake due to treatment effect. Patients will be followed for up to 3 days after the injection of radiolabeled ligand for evaluation of adverse events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor population | Experimental | Drug: 68Ga-FXX489, Procedure: Positron Emission Tomography (PET) imaging, Drug: Gallium-68 labelled (68Ga-) FAP-2286PET imaging will begin 30 +/-10 minutes, 60 +/-15 minutes and 120 +/-20 minutes after injection of 68Ga-FXX489 or 68Ga-FAP-2286 or 18F-FDG. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a high suspicion of oncological diseases.
- Age: 18-80 years, no gender restriction, able to express themselves independently, and willing to participate in this study with a signed informed consent form.
Key exclusion criteria (7 listed)
- Failure to sign the informed consent form.
- Severe visual or auditory impairment, cognitive disorders, or patients with claustrophobia who cannot communicate effectively.
- Severe cardiac dysfunction, cardiac function class III-IV.
- Renal failure (serum creatinine level > 1.2 mg/dl).
- Allergy to alcohol.
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-FXX489The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging. | Drug | Tumor population |
| Positron Emission Tomography (PET) imagingParticipants will be scanned for approximately 30 to 45 minutes. | Procedure or surgery | Tumor population |
| Gallium-68 labelled (68Ga-) FAP-2286The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging. | Drug | Tumor population |
Primary outcome
Count of participants with treatment-emergent adverse events
Time frame: Up to 3 days
The frequency and severity of treatment emergent adverse events following FXX489(NNS306) injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Proportion of radiation-absorbed doses of radiolabeled FAP-2286.
Time frame: Up to 3 days
Volumes of interest of 68Ga- will be drawn around regions identified on the scans, including the liver, spleen, kidneys, urinary bladder, the central sacrum (for hematopoietic marrow) and whole body. Data will be fitted using the Simulation, Analysis, and Modeling Software II (SAAM II) software. Time integrals of activity will be entered into the Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM) software, using the reference adult model. The results from all patients enrolled will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs
Standardized Uptake Values (SUVs)
Time frame: Up to 3 days
The maximum Standardized Uptake Value (SUVmax) will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity.
Tumor-to-background (TBR) Ratio
Time frame: Up to 3 days
TBR ratios will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity. The median and range of the measured TBRs will be reported across all RECIST measurable lesions as a table broken down by location (organ metastases, nodal metastases and bone metastases).
Proportion of positive lesions on FXX489(NNS306) PET
Time frame: Up to 3 days
Conventional imaging will be reviewed in conjunction with the FXX489(NNS306) PET images. Lesions will be characterized as positive on FXX489(NNS306) PET if uptake is greater than 1.5 times higher than mediastinal blood pool and uptake cannot be attributed to physiologic or inflammatory reasons. Conventional imaging will be interpreted as positive by each lesion if the short axis dimension of lymph nodes is greater than 1 centimeter (cm), and organ metastases measure greater than 1 cm in long axis. The gold standard will be the combination of conventional imaging and FXX489(NNS306) PET in combination with clinical follow-up and histopathology (if available). The number of lesions detected by each modality will be compared and sensitivity will be computed. Since this is a proof-of-concept study, it is not powered for the test of agreement. Nevertheless, the agreement will be tested using McNemar's test.
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 3 Apr 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.
Xuena Li study director
Department of Nuclear Medicine, The First Hospital of China Medical University
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-FXX489, Positron Emission Tomography (PET) imaging and Gallium-68 labelled (68Ga-) FAP-2286 in people with Tumor and Metastatic Cancer, run by Yi Tian 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 7 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 3 Apr 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 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 Xuena Li (0086-18040099351, lixuenacmunm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of participants with treatment-emergent adverse events (time frame: Up to 3 days). The study lists 5 primary outcomes in all. 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 3 Apr 2026.