HER2-positive tumors
Conditions
Interventions
Test group:68Ga DOTA-Y2 and 18F FDG PET/CT imaging
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Eligibility Criteria: 1. Aged 18 to 75 years inclusive; 2. Legally competent, voluntarily participating in this clinical study, and having signed an informed consent form (ICF); 3. Patients with confirmed solid tumours (breast cancer, gastric cancer, urothelial carcinoma, lung cancer, ovarian cancer); 4. HER2 status confirmed within the last 3 months (IHC 3+ or IHC 2+ with positive ISH/FISH); 5. No prior treatment for this tumour involving: tumour resection/curative surgery (excluding diagnostic biopsy), radiotherapy (including brachytherapy), systemic antineoplastic agents (chemotherapy, small-molecule targeted therapies, monoclonal antibodies, etc.), or investigational treatments in other clinical trials.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Patients with concurrently diagnosed malignant tumours; 2. Patients with uncontrolled severe infections or concomitant serious illnesses; 3. Patients with an expected survival period <= 3 months; 4. Pregnant or lactating patients, and patients of childbearing potential who refuse to use appropriate contraceptive measures during the trial; 5. Patients with known hypersensitivity to any component of the formulation; 6. Patients deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medication Safety;Radiation Absorption Dose Characteristics;Biodistribution Profile;PET Imaging Characteristics;The correlation between PET imaging and HER2 expression levels as measured by immunohistochemistry (IHC);Diagnostic Efficacy; | — |
Countries
China
Contacts
Public ContactDai Dong
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed