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

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 Overview

• Status: Recruiting
• Conditions: Solid Tumors

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Zhangqian Zhang; Phone Number: 13765839835; Email: 1806708691@qq.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing cancer hosipitaal
      • Contact: Qian Zhang; Phone Number: 137655839835; Email: 1806708691@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with pathologically confirmed newly diagnosed solid tumors

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
solid tumor; diagnosed solid tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	SUVmax and SUVmean	Imaging and analysis were performed 2, 24, and 48 hours after drug injection
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).	SUVmax and SUVmean	Imaging and analysis were performed 2, 24, and 48 hours after drug injection

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 14, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025KT202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No