Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- To evaluate the diagnostic and staging accuracy of ⁸⁹Zr-s-C1 PET/CT imaging in patients with MUC18-positive solid tumors, particularly for lesions that remain indeterminate with conventional imaging modalities or ¹⁸F-FDG PET/CT.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Case inclusion criteria
- •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.
- •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.
- •Expected survival ≥ 12 weeks.
- •Good compliance with follow-up.
- •Presence of at least one measurable target lesion according to RECIST 1.1 criteria.
- •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.
- •Subjects must fully understand and voluntarily participate in this trial, and sign the Informed Consent Form.
Exclusion Criteria
- •Severe liver and kidney dysfunction.
- •Women preparing for pregnancy, pregnant, or breastfeeding.
- •Inability to lie flat for half an hour.
- •Inability to provide informed consent.
- •Suffering from claustrophobia or other psychiatric disorders.
- •Known allergy to the investigational drug or its excipients.
- •Other situations deemed unsuitable for trial participation by the researchers.
Arms & Interventions
solid tumor
diagnosed solid tumor
Outcomes
Primary Outcomes
To evaluate the diagnostic and staging accuracy of ⁸⁹Zr-s-C1 PET/CT imaging in patients with MUC18-positive solid tumors, particularly for lesions that remain indeterminate with conventional imaging modalities or ¹⁸F-FDG PET/CT.
Time Frame: Imaging and analysis were performed 2, 24, and 48 hours after drug injection
SUVmax and SUVmean
Measure the maximum standardized uptake value (SUVmax) of tumor lesions and compare it with that of surrounding normal tissues (such as the liver and muscles) to calculate the tumor-to-background ratio (TBR).
Time Frame: Imaging and analysis were performed 2, 24, and 48 hours after drug injection
SUVmax and SUVmean
Secondary Outcomes
No secondary outcomes reported
Investigators
Hua Zhu
Professor
Peking University Cancer Hospital & Institute