TF-antigen Targeting Molecular Probe for PET Imaging in Solid Tumors

NCT06755086 | Not Yet Recruiting

• 1 other identifier: 2024YJZ123
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to construct a noninvasive approach using 124I-labeled monoclonal antibody radiotracer to detect the Thomsen-Friedenreich antigen (TF-antigen, CD176) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from TF-antigen targeting treatment.

Conditions

Solid Tumors

Keywords

Solid Tumors; TF-antigen; CD176; PET imaging

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value（SUV）

  SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions. The uptake of the tracer （124I-hJAA-F11） in solid tumor lesions by measuring SUV on PET/CT.

  2 years

Study Arms (1)

124I-hJAA-F11

All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 124I-hJAA-F11 PET/CT scan.

Drug: 18-FDG

Interventions

18-FDG DRUG

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

124I-hJAA-F11

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Malignant tumor patients or suspected patients

You may qualify if:

• Age ≥ 18 and ≤ 75 years, male or female;
• ECOG performance status score of 0 or 1;
• Expected survival time ≥ 6 months;
• At least one measurable tumor lesion exists according to RECIST 1.1 criteria (e.g., lung cancer, gastric cancer, colorectal cancer, breast cancer, pancreatic cancer, hepatocellular carcinoma). The lesion must be eligible for biopsy within one month before or after a PET scan, and the patient must be able to provide 2-3 tissue slices of the lesion;
• Subjects must fully understand and voluntarily agree to participate in the study and sign an informed consent form.

You may not qualify if:

• Pregnant or breastfeeding women, or women planning to become pregnant during the study period or within three months after drug administration, as well as individuals donating sperm or eggs;
• Individuals known or suspected to be allergic to the investigational drug or any of its components;
• Individuals with significantly impaired liver or kidney function;
• Individuals unable to comply with PET examinations or those with conditions such as claustrophobia that prevent them from undergoing PET scans.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Central Study Contacts

Hua Zhu

CONTACT

010-88196495; zhuhuabch@pku.edu.cn

Zhi Yang

CONTACT

010-88196196; pekyz@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)