Research on Early Diagnosis and Clinical Transformation of Nuclide Probe Based on Bioorthogonal-gastric Cancer Mucin Target Visualization

NCT ID: NCT06429891

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2026-12-31

Brief Summary

The symptoms of early gastric cancer are extremely insidious and most patients are identified as advanced at the time of initial diagnosis. Starting from the clinical needs, this project selects solid tumors and pathogenic glycoprotein synthesis of key glycopeptide antigen determinant mucin (MUC) family of multiple molecules as the research object. Based on the digestive system tumor research cohort established in the early stage, this project intends to verify the tumor microenvironment characteristics of the MUC family and gastric cancer treatment resistance through immunohistochemistry, COSMC gene sequencing and other technologies, and screen key MUC family proteins. Based on the discovery of differential recognition of COSMC deficient cells by antibodies, MUC1-targeted specific monoclonal antibody was developed. Further development of spatial mucinomics based on laser ablation inductively coupled plasma mass spectrometry (LA-IPC-MS) and spatial metabolome based on desorption electrospray mass spectrometry (DESI-MS) to analyze the structure and immunosuppressive mechanism of key gastric cancer glycoprotein MUC. After obtaining key targeted antibodies, with the help of biological orthogonal and click chemistry technology, the original clinical translational research based on mucin targeting was carried out, and a high-affinity nuclide conjugate drug (RDC) with "triple binding" of gastric cancer mucin was constructed and clinical translational research was carried out, which provided new ideas for the accurate diagnosis and treatment of gastric cancer in the early stage.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

89Zr-16A

All study participants will be allocated to this arm (single-arm study). Study participants will undergo 89Zr-16A PET/CT scans.

Group Type: EXPERIMENTAL

18F-FDG

Intervention Type: DRUG

All study participants will undergo one 18F-FDG PET/CT scan.

Interventions

18F-FDG

All study participants will undergo one 18F-FDG PET/CT scan.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged ≥18 years old; ECOG 0 or 1;

2. Patients with solid tumor confirmed by histopathology;

3. Patients with imaging confirmed measurable lesions;

4. life expectancy >=12 weeks.

Exclusion Criteria

1. Significant hepatic or renal dysfunction;

2. ls pregnant or ready to pregnant;

3. Cannot keep their states for half an hour;

4. Refusal to join the clinical study;

5. Suffering from claustrophobia or other mental diseases；

6. Any other situation that researchers think it is not suitable to participate in the experiment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hua Zhu

OTHER

Sponsor Role: lead

Responsible Party

Hua Zhu

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hua Zhu

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hua Zhu

Role: CONTACT

zhuhuabch@pku.edu.cn

+861088196495

Facility Contacts

Hua Zhu, Dr.

Role: primary

zhuhuananjing@163.com

+861088196495

Other Identifiers

2024KT68

Identifier Type: -

Identifier Source: org_study_id