NCT07529002 Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 20 participants in total. It began in 2026-04-14 with a primary completion date of 2028-03-01.

Brief Summary

This project is driven by clinical needs and focuses on the mucin (MUC) family, key glycopeptide antigens involved in mediating immune evasion in solid tumors. We selected multiple members of this family as research subjects. Based on the MUC18 target, we developed the probe ⁸⁹Zr-SS-CNB001 (HuAA98-14, hereafter referred to as ⁸⁹Zr-s-C1). Studies have demonstrated that ⁸⁹Zr-s-C1 PET/CT enables noninvasive in vivo identification of tumor lesions in patients with solid tumors, and its imaging efficacy positively correlates with MUC18 expression levels in the patient's tumor tissue.

Eligibility Criteria

Case inclusion criteria 1. Patients with pathologically confirmed newly diagnosed solid tumors (such as melanoma, gastric cancer, colorectal cancer, etc.), or those with recent recurrence or suspected recurrence of previous solid tumors. Both male and female patients are eligible. 2. Hematology, liver, and kidney function meeting the following criteria: Hematology: WBC ≥ 4.0×10⁹/L or neutrophil count ≥ 1.5×10⁹/L, PLT ≥ 100×10⁹/L, Hb ≥ 90 g/L; PT or APTT ≤ 1.5 × ULN. Liver and kidney function: T-Bil ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN for subjects with liver metastases), ALP ≤ 2.5 × ULN (if bone or liver metastases are present, ALP ≤ 4.5 × ULN); BUN ≤ 1.5 × ULN, SCr ≤ 1.5 × ULN. 3. Expected survival ≥ 12 weeks. 4. Good compliance with follow-up. 5. Presence of at least one measurable target lesion according to RECIST 1.1 criteria. 6. Female subjects must use effective contraception (effective contraception refers to sterilization, intrauterine hormone devices, condoms, contraceptive pills/agents, abstinence, or vasectomized partner) during the study and for 6 months after the study ends; male subjects must agree to use contraception during the study and for 6 months after the study ends. 7. Subjects must fully understand and voluntarily participate in this trial, and sign the Informed Consent Form. Case exclusion criteria 1. Severe liver and kidney dysfunction. 2. Women preparing for pregnancy, pregnant, or breastfeeding. 3. Inability to lie flat for half an hour. 4. Inability to provide informed consent. 5. Suffering from claustrophobia or other psychiatric disorders. 6. Known allergy to the investigational drug or its excipients. 7. Other situations deemed unsuitable for trial participation by the researchers.

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