This study is being done to test a new imaging agent called 68Ga-SFB6-ZN01, which helps visualize tumors using PET/CT scans. The agent attaches to a protein called integrin αvβ6, which is found on the surface of many cancer cells but rarely on normal cells. A total of 98 adults who either have a confirmed cancer diagnosis, are strongly suspected of having cancer, or may have recurrent cancer after previous treatment will be enrolled. Each participant will receive a single injection of 68Ga-SFB6-ZN01 and undergo one PET/CT scan within one week of joining the study. The main goals are: to see how safe the imaging agent is and whether it causes any side effects; to understand how the agent distributes in the body, and how much radiation exposure it gives; to determine how accurately 68Ga-SFB6-ZN01 PET/CT can detect cancerous lesions and correctly stage the disease, using biopsy results or long-term follow-up (≥6 months) as the reference standard; to explore whether the PET signal intensity (e.g., SUVmax) correlates with the expression of integrin αvβ6 in the tumor tissue. No therapeutic treatment is given in this study. Participation involves one imaging visit and follow-up contact. The results will help determine whether this new tracer should be developed further for cancer imaging.
Voluntary written informed consent.
Age ≥ 18 years, male or female.
Clinically suspected or pathologically confirmed malignant solid tumor, or suspicion of recurrence after treatment.
Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.
Administration of any radionuclide within a period less than 10 physical half-lives before study agent injection.
Concurrent participation in another interventional clinical trial involving an investigational drug or device.
Known hypersensitivity to 68Ga-SFB6-ZN01 or any of its excipients.
Inability to lie flat or remain still during PET/CT acquisition, or any contraindication to PET/CT.
Single group
68Ga-SFB6-ZN01
DrugSingle intravenous bolus injection of 68Ga-SFB6-ZN01 (target activity: 111-185 MBq) followed by whole-body PET/CT scan at 60 ± 10 minutes post-injection.
Diagnostic Efficacy of 68Ga-SFB6-ZN01 PET/CT in Malignant Solid Tumors
Sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) of 68Ga-SFB6-ZN01 PET/CT for detecting malignant lesions (primary and metastatic), using histopathology as the reference standard and/or clinical/imaging follow-up of at least 6 months as the composite reference standard.
Safety and Tolerability: Incidence of Adverse Events
Incidence of adverse events graded by CTCAE v5.0 following a single microdose of 68Ga-SFB6-ZN01.
Safety and Tolerability: Relationship of Adverse Events
Relationship of adverse events to study agent (unrelated, possibly related, related) following a single microdose of 68Ga-SFB6-ZN01.
Safety and Tolerability: Severity of Adverse Events
Severity of adverse events graded by CTCAE v5.0 following a single microdose of 68Ga-SFB6-ZN01.
Biodistribution: Organ-Specific Standardized Uptake Values (SUV)
Organ-specific standardized uptake values (SUVmax and SUVmean) of 68Ga-SFB6-ZN01 measured from serial whole-body PET/CT scans in a subset of patients.
Correlation of PET Parameters with Histopathological Features
Correlation of SUVmax, SUVmean, TBRmax, TBRmean, and total lesion metabolism uptake (TLMU) with tumor grade, Ki-67 index, and integrin αvβ6 immunohistochemical expression (H-score).
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