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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.
Initially the investigator(s) will focus on imaging pancreatic cancer, lung cancer, breast cancer, gastric cancer, colorectal cancer.
STUDY AIMS
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FXX489 | Drug | The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuena Li | Contact | 0086-18040099351 | lixuenacmunm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuena Li | Department of Nuclear Medicine, The First Hospital of China Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2025 | Jan 13, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Positron Emission Tomography (PET) imaging | Procedure | Participants will be scanned for approximately 30 to 45 minutes. |
|
| Gallium-68 labelled (68Ga-) FAP-2286 | Drug | The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging. |
|
| Up to 3 days |