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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing cancer hosipitaal
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Zhangqian Zhang
• Email: 1806708691@qq.com
• Phone: 13765839835

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.