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

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

NCT07529002

Sponsor

Peking University Cancer Hospital & Institute

Status

Recruiting

Last Update Posted

Apr 14, 2026Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Solid Tumors

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2026Estimated

Primary Completion Date

Mar 1, 2028Estimated

Completion Date

Mar 1, 2028Estimated

First Submitted Date

Mar 20, 2026

First Submission Date that Met QC Criteria

Apr 12, 2026

First Posted Date

Apr 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2026

Last Update Posted Date

Apr 14, 2026Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
solid tumor		diagnosed solid tumor

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Case 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with pathologically confirmed newly diagnosed solid tumors

Sampling Method

Non-Probability Sample