An Open-label, Single-arm, Single-center Study to Evaluate the Diagnostic Efficacy of a Novel PET Probe, 68Ga-SFB6-ZN01, in Patients With Malignant Tumors

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* 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.
* Life expectancy ≥ 6 months.
* Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use highly effective contraception from consent until 6 months after study agent administration.

Exclusion Criteria:

* 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.
* Pregnancy or breastfeeding.
* Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation.

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