TF-antigen Targeting Molecular Probe for PET Imaging in Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18-FDG.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Analysis plan: 1. Recruit 3-5 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution, and tumor uptake information via whole-body PET/CT imaging; 2. Recruit 20 participants to analyze in vivo safety and tumor targeting information; 3. Recruit all participants for a final summary.
Interventions
- Drug 18-FDG
All study participants will undergo one 18F-FDG PET/ CT scan.
Primary outcome measures
- Standardized uptake value（SUV） [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT06755086 · 2024YJZ123