89Zr-s-C1 PET/CT imaging to find MUC18-expressing solid tumors

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

This project will test whether a new PET/CT tracer, 89Zr-s-C1, can detect tumor lesions in people with solid tumors and reflect MUC18 expression.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 15 Years to 70 Years
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07529002 on ClinicalTrials.gov

What this trial studies

This observational project uses a radiolabeled antibody probe, 89Zr-SS-CNB001 (HuAA98-14, called 89Zr-s-C1), to perform PET/CT imaging in patients with newly diagnosed or recurrent solid tumors. Participants with measurable lesions undergo noninvasive PET/CT scanning with 89Zr-s-C1 to identify tracer uptake and lesion distribution. Imaging findings are compared with tumor tissue MUC18 expression to examine the relationship between tracer signal and antigen levels. Enrollment requires adequate blood counts, liver and kidney function, an expected survival of at least 12 weeks, and the ability to comply with follow-up.

Who should consider this trial

Good fit: Adults with pathologically confirmed newly diagnosed or recurrent solid tumors who have at least one measurable lesion by RECIST 1.1, adequate hematology/liver/kidney function, expected survival ≥12 weeks, and ability to use effective contraception if female would be suitable candidates.

Not a fit: Patients without measurable lesions, with poor organ function or short expected survival, who are pregnant, or whose tumors lack MUC18 expression may not benefit from this imaging approach.

Why it matters

Potential benefit: If successful, this imaging approach could help detect MUC18-positive tumor lesions more accurately and guide treatment decisions.

How similar studies have performed: Preclinical work and early clinical use have shown that 89Zr-s-C1 PET/CT can identify tumor lesions and that uptake correlates with MUC18 expression, though broader clinical validation remains limited.

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing cancer hosipitaal — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhangqian Zhang

Conditions Solid Tumors